Caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors

Emily H Morgan; Anel Schoonees; Urshila Sriram; Marlyn Faure; Rebecca A Seguin‐Fowler

doi:10.1002/14651858.CD012547.pub2

. 2020 Jan 5;2020(1):CD012547. doi: 10.1002/14651858.CD012547.pub2

Caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors

Emily H Morgan ^1,^✉, Anel Schoonees ², Urshila Sriram ^3,⁴, Marlyn Faure ⁵, Rebecca A Seguin‐Fowler ^4,⁶

Editor: Cochrane Developmental, Psychosocial and Learning Problems Group

PMCID: PMC6956675 PMID: 31902132

Abstract

Background

Poor diet and insufficient physical activity are major risk factors for non‐communicable diseases. Developing healthy diet and physical activity behaviors early in life is important as these behaviors track between childhood and adulthood. Parents and other adult caregivers have important influences on children's health behaviors, but whether their involvement in children's nutrition and physical activity interventions contributes to intervention effectiveness is not known.

Objectives

• To assess effects of caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors, including those intended to prevent overweight and obesity

• To describe intervention content and behavior change techniques employed, drawing from a behavior change technique taxonomy developed and advanced by Abraham, Michie, and colleagues (Abraham 2008; Michie 2011; Michie 2013; Michie 2015)

• To identify content and techniques related to reported outcomes when such information was reported in included studies

Search methods

In January 2019, we searched CENTRAL, MEDLINE, Embase, 11 other databases, and three trials registers. We also searched the references lists of relevant reports and systematic reviews.

Selection criteria

Randomised controlled trials (RCTs) and quasi‐RCTs evaluating the effects of interventions to improve children's dietary intake or physical activity behavior, or both, with children aged 2 to 18 years as active participants and at least one component involving caregivers versus the same interventions but without the caregiver component(s). We excluded interventions meant as treatment or targeting children with pre‐existing conditions, as well as caregiver‐child units residing in orphanages and school hostel environments.

Data collection and analysis

We used standard methodological procedures outlined by Cochrane.

Main results

We included 23 trials with approximately 12,192 children in eligible intervention arms. With the exception of two studies, all were conducted in high‐income countries, with more than half performed in North America. Most studies were school‐based and involved the addition of healthy eating or physical education classes, or both, sometimes in tandem with other changes to the school environment. The specific intervention strategies used were not always reported completely. However, based on available reports, the behavior change techniques used most commonly in the child‐only arm were "shaping knowledge," "comparison of behavior," "feedback and monitoring," and "repetition and substitution." In the child + caregiver arm, the strategies used most commonly included additional "shaping knowledge" or "feedback and monitoring" techniques, as well as "social support" and "natural consequences."

We considered all trials to be at high risk of bias for at least one design factor. Seven trials did not contribute any data to analyses. The quality of reporting of intervention content varied between studies, and there was limited scope for meta‐analysis. Both validated and non‐validated instruments were used to measure outcomes of interest. Outcomes measured and reported differed between studies, with 16 studies contributing data to the meta‐analyses. About three‐quarters of studies reported their funding sources; no studies reported industry funding. We assessed the quality of evidence to be low or very low.

Dietary behavior change interventions with a caregiver component versus interventions without a caregiver component

Seven studies compared dietary behavior change interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (mean difference [MD] −0.42%, 95% confidence interval [CI] −1.25 to 0.41, 1 study, n = 207; low‐quality evidence) or from sodium intake (MD −0.12 g/d, 95% CI −0.36 to 0.12, 1 study, n = 207; low‐quality evidence). No trial in this comparison reported data for children's combined fruit and vegetable intake, sugar‐sweetened beverage (SSB) intake, or physical activity levels, nor for adverse effects of interventions.

Physical activity interventions with a caregiver component versus interventions without a caregiver component

Six studies compared physical activity interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's total physical activity (MD 0.20 min/h, 95% CI −1.19 to 1.59, 1 study, n = 54; low‐quality evidence) or moderate to vigorous physical activity (MVPA) (standard mean difference [SMD] 0.04, 95% CI −0.41 to 0.49, 2 studies, n = 80; moderate‐quality evidence). No trial in this comparison reported data for percentage of children's total energy intake from saturated fat, sodium intake, fruit and vegetable intake, or SSB intake, nor for adverse effects of interventions.

Combined dietary and physical activity interventions with a caregiver component versus interventions without a caregiver component

Ten studies compared dietary and physical activity interventions with and without a caregiver component. At the end of the intervention, we detected a small positive impact of a caregiver component on children's SSB intake (SMD −0.28, 95% CI −0.44 to −0.12, 3 studies, n = 651; moderate‐quality evidence). We did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (MD 0.06%, 95% CI −0.67 to 0.80, 2 studies, n = 216; very low‐quality evidence), sodium intake (MD 35.94 mg/d, 95% CI −322.60 to 394.47, 2 studies, n = 315; very low‐quality evidence), fruit and vegetable intake (MD 0.38 servings/d, 95% CI −0.51 to 1.27, 1 study, n = 134; very low‐quality evidence), total physical activity (MD 1.81 min/d, 95% CI −15.18 to 18.80, 2 studies, n = 573; low‐quality evidence), or MVPA (MD −0.05 min/d, 95% CI −18.57 to 18.47, 1 study, n = 622; very low‐quality evidence). One trial indicated that no adverse events were reported by study participants but did not provide data.

Authors' conclusions

Current evidence is insufficient to support the inclusion of caregiver involvement in interventions to improve children's dietary intake or physical activity behavior, or both. For most outcomes, the quality of the evidence is adversely impacted by the small number of studies with available data, limited effective sample sizes, risk of bias, and imprecision. To establish the value of caregiver involvement, additional studies measuring clinically important outcomes using valid and reliable measures, employing appropriate design and power, and following established reporting guidelines are needed, as is evidence on how such interventions might contribute to health equity.

Plain language summary

Effects of involving parents and other adult caregivers in children's diet and physical activity interventions

Review question

Does it make a difference if parents or other adult caregivers are involved in interventions to encourage children to eat healthier or be more physically active?

Background

Diet and physical activity behaviors are important determinants of health. Parents and other adult caregivers have an essential role in shaping children's health habits by controlling availability of and access to healthy foods and opportunities to be active; supporting, encouraging, and role‐modeling healthy behaviors; and adopting supportive feeding styles and practices. For these reasons, it often is argued that parent and caregiver involvement in children's diet and physical activity interventions is important; however, it remains unclear if involvement of parents and caregivers actually provides benefit.

Objectives

We assessed the effects of involving parents or other adult caregivers in children's healthy eating and physical activity interventions compared to the effects of the same child interventions without a parent or caregiver component. We were particularly interested in understanding effects on children's dietary intake, children's physical activity levels, and adverse effects of interventions.

Study characteristics

We found 23 studies, published between 1982 and 2019, that implemented diet interventions, physical activity interventions, or combined diet and physical activity interventions with children or adolescents, and evaluated the effects of adding an intervention component involving parents or other adult caregivers. Approximately 12,192 children aged 2 to 18 years were examined. More than half of studies took place in North America, and all but two were conducted in high‐income countries. Most studies were school‐based and involved the addition of healthy eating or physical education classes, or both, sometimes in tandem with other changes to the school environment. The breadth of information provided about intervention content varied between studies. The most commonly used intervention techniques were those aimed at shaping participants' knowledge, such as providing instruction about how to perform a behavior (e.g. dance, cooking lessons). About three‐quarters of studies reported their funding source; no studies reported industry funding.

Key results

The findings of this review suggest that adding a parent or caregiver component to dietary behavior change interventions or physical activity interventions may make little or no difference to children's dietary intake or physical activity levels. For interventions that target both diet and physical activity behaviors, involving a parent or caregiver probably slightly reduces children's sugar‐sweetened beverage intake by the end of the intervention. We do not know whether any of these types of interventions result in adverse effects because these data are not available.

Quality of evidence

Overall, the evidence from studies is of low or very low quality, which means that we are uncertain about study results.

Currentness of evidence

The evidence is current to January 2019.

Summary of findings

Background

Description of the condition

Non‐communicable diseases (NCDs), including cardiovascular diseases, cancer, type 2 diabetes mellitus, chronic respiratory diseases, and chronic kidney disease, are the leading causes of disability worldwide (Lozano 2012), and they account for more than two‐thirds of all global deaths (NCD Countdown 2030 Collaborators 2018). In 2015, the United Nations set reducing the probability of dying between 30 years and 70 years of age from NCDs as Sustainable Development Goal (SDG) target 3.4 (United Nations 2015). Poor diet and insufficient physical activity are important independent risk factors for NCD development and for obesity, and are leading contributors to the global burden of disease (Forouzanfar 2016; GBD 2017 Diet Collaborators 2019). In fact, recent research suggests that poor diet is responsible for more deaths globally than any other risk factor, including smoking tobacco (GBD 2017 Diet Collaborators 2019). In light of this impact, diet and physical activity behaviors have been identified as priority areas for public health action (Beaglehole 2011; WHO 2013; WHO 2016). Because these behaviors develop early in life, children and adolescents are a target population for prevention (WHO 2013; WHO 2016).

Low consumption of nutritious foods, such as fruits, vegetables, whole grains, nuts, and seeds, is a major contributor to disease burden (GBD 2017 Diet Collaborators 2019). Meta‐analyses have shown that fruits and vegetables have a significant protective effect for ischemic heart disease and stroke (Gan 2015; Hu 2014), and it is likely that they protect against some types of cancer (Marmot 2007; Wang 2014). The World Health Organization (WHO) recommends consuming at least 400 grams of fruits and vegetables per day (equivalent to five 80‐gram servings) to prevent chronic diseases (WHO 2003). However, an estimated 78% of the world population does not meet this recommendation (Hall 2009). Similarly, there is strong evidence linking increased intake of whole grains, nuts, and seeds to reduced risk of cardiovascular disease and type 2 diabetes (Afshin 2014; Ye 2012), but low consumption of these foods is widespread (GBD 2017 Diet Collaborators 2019; Micha 2015). In 2017, low intake of whole grains was the leading dietary risk factor for mortality among women and the second most important risk factor for mortality among men (GBD 2017 Diet Collaborators 2019). Other dietary factors associated with health benefits include omega‐3 fatty acids from seafood, fiber, polyunsaturated fatty acids, milk, and calcium (GBD 2017 Diet Collaborators 2019).

Reducing intake of sodium, processed and red meats, trans fats, and sugar‐sweetened beverages (SSBs) is recommended to promote population health and to prevent NCDs (GBD 2017 Diet Collaborators 2019; UN General Assembly 2012; WHO 2013). For decades, sodium intake has been associated with hypertension and NCDs, particularly cardiovascular disease (He 2009). The WHO recommends sodium intake no greater than 2 grams per day (equivalent to 5 grams of salt) (WHO 2003), but most populations consume much more (Brown 2009; GBD 2017 Diet Collaborators 2019). In 2010, global mean sodium intake was nearly twice the recommended limit (Powles 2013). Findings from prospective studies have shown consumption of processed and red meats to be associated with type 2 diabetes and colorectal cancer (Chan 2011; Micha 2012). There is also a link between processed meat and ischemic heart disease, likely due in part to the high sodium content of processed meat (Micha 2012). Evidence from controlled trials and observational studies indicates that trans fatty acids also adversely affect cardiovascular indicators and increase risk of ischemic heart disease (Mozaffarian 2009; Teegala 2009). Furthermore, meta‐analyses of prospective studies have found SSB consumption to be associated with weight gain (Malik 2013), type 2 diabetes (Imamura 2015; Malik 2010), hypertension (Xi 2015), ischemic heart disease (Huang 2014; Xi 2015), and chronic kidney disease (Cheungpasitporn 2014).

At the same time, physical activity is associated with numerous health benefits (Lee 2012), including protection against cardiovascular disease (Sofi 2008), type 2 diabetes (Jeon 2007), certain types of cancer (Thune 2001), and cardiovascular disease−related death (Lee 2012; Nocon 2008). Despite this, available data suggest a global inactivity crisis. Worldwide, 31% of adults and 80% of adolescents do not meet minimum recommendations for physical activity (Hallal 2012). A 15‐country comparison involving high‐, middle‐, and low‐income countries found that no countries had at least 80% of children and adolescents meeting physical activity guidelines (Tremblay 2014). Insufficient physical activity accounts for more than 5.3 million deaths per year, or 9% of premature mortality (Lee 2012). Even among physically active people, prolonged sedentary behavior is associated with higher risk of type 2 diabetes, cardiovascular disease, and cardiovascular and all‐cause mortality (Biswas 2015; Wilmot 2012).

In all world regions, the prevalence of obesity among children and adolescents has increased in recent decades (Black 2013; De Onis 2010; Lobstein 2015; Ng 2014). A global shift in diet toward highly processed foods, meat, and dairy products, combined with increases in sedentary behavior, is believed to have contributed to this phenomenon (Popkin 2013). Social inequalities in child and adolescent obesity are well documented. Although prevalence is highest in high‐income countries, most overweight children younger than five years live in low‐ and middle‐income countries (Black 2013). In high‐income countries, excess weight is more common among socially disadvantaged groups, but the inverse may be true in low‐ and middle‐income countries (Barriuso 2015; Chung 2016; Dinsa 2012; Wu 2015). Epidemiologic evidence suggests that diet quality and activity levels follow a socioeconomic gradient. In high‐income countries, greater socioeconomic position is associated with higher‐quality diets, more physical activity, and less sedentary time (Bauman 2012; Darmon 2008; Mayén 2014; Mielke 2016; Stalsberg 2010). High levels of obesity appear to be more prevalent in high‐income countries with greater income inequality than in high‐income countries with less income inequality (Wilkinson 2011). Data from low‐ and middle‐income countries are more limited, but available information suggests that associations between social advantage and obesity‐related behaviors differ from those observed in high‐income countries. For instance, in low‐ and middle‐income countries, adolescents from the wealthiest households appear to be the most sedentary (Mielke 2016). One reason for this could be that lower socioeconomic groups have to rely on walking or cycling for transportation and may be more likely to work in physically demanding jobs, such as farm or factory labor. For the most disadvantaged, obesity may co‐occur with undernutrition or micronutrient deficiencies due to common underlying factors or physiological links (Tzioumis 2014).

Overweight conditions in childhood and adolescence are associated with immediate and longer‐term health risks and decreased quality of life (Buttitta 2014; Daniels 2009). Virtually every organ system is adversely impacted by excess body weight, including cardiovascular, metabolic, pulmonary, gastrointestinal, and skeletal systems. Related health conditions in overweight and obese youth include cardiovascular disease symptoms, type 2 diabetes, breathing disorders, and fatty liver disease (Daniels 2009; Pulgarón 2014). Excess adiposity during childhood also can influence pubertal development in both boys and girls (Solorzano 2010). In addition, overweight children and adolescents experience psychological comorbidities such as internalizing disorders (e.g. anxiety, depression), externalizing disorders (e.g. impulsivity, attention deficit hyperactivity disorder), sleep problems, and uncontrolled eating (Puder 2010; Pulgarón 2014).

There is a strong correlation between childhood obesity and adult obesity (Simmonds 2016). Current trends suggest that young people today—particularly those from marginalized or otherwise vulnerable population groups—could suffer greater illness and live shorter lives than previous generations (Olshansky 2005). Developing healthy diet and physical activity behaviors during childhood and adolescence is an important step in preventing obesity and NCDs, particularly because these behaviors are likely to track into adulthood (Craigie 2011). For example, long‐term prospective cohort studies have found that diet and television viewing habits in childhood are predictors of similar behaviors decades later (Mikkilä 2005; Smith 2015). Consequently, early intervention is emphasized to instil healthy behaviors and to prevent the onset of overweight and obesity.

Description of the intervention

Interventions to improve children's and adolescents' health behaviors often encompass multiple components, including education, environmental modifications, and caregiver involvement. Narrative reviews have consistently argued that involving parents or other adult caregivers is important (Bautista‐Castaño 2004; Golan 2004; Lindsay 2006; McLean 2003; Sharma 2006). For childhood obesity interventions, some meta‐analyses have shown that parent and family involvement contributes to their success (Niemeier 2012; Young 2007), although these benefits may not be retained in the long run (Yavuz 2015). Caregiver involvement could comprise a range of behavior change techniques such as providing information or instruction, prompting intention formation, identifying barriers, self‐monitoring, offering opportunities for social comparison, or restructuring environments (Golley 2011). However, interventions that involve caregivers show inconsistent effectiveness (Stice 2006), and it is unclear which kinds of caregiver involvement lead to more effective outcomes. Without this information, it is not possible to specify the types of caregiver involvement and intervention strategies that may promote behavior change.

How the intervention might work

Parents and other adult caregivers have important influences on child development and play an essential role in shaping children's and adolescents' diet and physical activity habits by providing the contextual environment within which they develop these behaviors (De Vet 2011; Draper 2015; Golan 2004; Lindsay 2006; Patrick 2005). Caregivers' involvement in interventions could work through a number of mechanisms. Physical aspects of the home environment, which are largely controlled by caregivers, appear to be related to what children eat and to their physical activity levels. For example, less access to fruits and vegetables at home is associated with lower consumption among children and adolescents (Pearson 2009), and the presence of electronic media in children's bedrooms has been related to sedentary behavior (Tandon 2012). Outside of the home, caregivers may serve as gatekeepers to physical activity by establishing the activities in which children can participate.

Caregivers also have an important psychosocial influence on children's habit formation. Children are more likely to eat a healthy diet when their caregivers model healthy eating themselves (De Vet 2011; Golan 2004; Patrick 2005; Pearson 2009; Skouteris 2011). Additionally, caregivers' feeding styles and practices and nutrition knowledge, as well as food beliefs, attitudes, and preferences, have been shown to be associated with children's diets (Blissett 2011; Clark 2007; Draper 2015; Golan 2004; Patrick 2005; Scaglioni 2011; Skouteris 2011). Consequently, it follows that intervention activities targeted at caregivers may be beneficial for supporting and promoting healthy eating and physical activity among children and adolescents.

Current theories of child development are based on the transactional view, which emphasizes the interdependent and bidirectional effects of interactions between the child and his or her social settings (Sameroff 2010). Caregivers and children are continuously interacting, both shaping and being shaped by the other's actions. As children move from early childhood into adolescence, caregiver and family influences often decrease as peer influences become more important (National Research Council 2004; Sameroff 2010). However, caregivers continue to influence diet, physical activity, and sedentary behaviors (Draper 2015). Given the continual shifts in child−caregiver relationships as children grow, the most beneficial forms of caregiver involvement and behavior change techniques to promote child behavior change may differ for different child age groups. A systematic review of universal parental support interventions to promote healthy dietary habits and physical activity behaviors or to prevent overweight and obesity among children found that these interventions appear to work better when children are younger (Kader 2015).

Why it is important to do this review

Improving health‐related behavior among children and adolescents has the potential to improve the overall health of the next generation and to reduce the burden of NCDs. At least four Cochrane Reviews have indicated a need for greater attention to the involvement of caregivers in behavior change interventions. Waters 2011 and Brown 2019 evaluated effects of childhood obesity prevention interventions but did not distinguish which intervention components contributed to favorable effects. Luttikhuis 2009 focused on treatment of children with obesity and included studies with or without family involvement, but review authors did not perform a subgroup analysis on family involvement. Loveman 2015 examined the efficacy of diet, physical activity, and behavioral interventions delivered to parents only for treatment of overweight and obesity in children and found limited evidence that parental interventions helped reduce child body mass index (BMI).

A number of other reviews have explored the contributions of caregiver involvement (in particular, parents) to children's nutrition and physical activity interventions (Golley 2011; Hingle 2010; Kader 2015; Ling 2017; Morris 2015; Niemeier 2012; O'Connor 2009; Van Lippevelde 2012). Some reviews concluded that caregiver involvement promotes intervention success (Golley 2011; Niemeier 2012), but others suggested that evidence to support the claim that caregiver involvement is important in children's nutrition and physical activity interventions is lacking (Hingle 2010; Kader 2015; Ling 2017; Morris 2015; O'Connor 2009; Van Lippevelde 2012). In addition, the effects of different behavior change techniques employed with caregivers are not yet established.

Our review aimed to fill this evidence gap by updating and expanding upon a previous review (Van Lippevelde 2012), which sought to assess the contributions of parental (i.e. caregiver) involvement to intervention effectiveness. The previous review focused on "determining the impact of parental involvement in school‐based obesity prevention interventions" (targeting both nutrition‐ and physical activity−related behaviors) for children aged 6 to 18 years and considered evidence published between 1990 and 2010. Our review incorporated a broader scope of research evidence by including both school‐based and non−school‐based interventions as well as studies targeting children and adolescents aged 2 to 18 years. When the data allowed, we considered which behavior change techniques were employed. To support the growing demand for information on effects of interventions on health equity, we also evaluated how the interventions were implemented, and whether study authors reported on sociodemographic factors known to be important from an equity perspective.

Objectives

To assess effects of caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors, including those intended to prevent overweight and obesity
To describe intervention content and behavior change techniques employed, drawing from a behavior change technique taxonomy developed and advanced by Abraham, Michie, and colleagues (Abraham 2008; Michie 2011; Michie 2013; Michie 2015)
To identify content and techniques related to reported outcomes when such information was reported in included studies

Methods

Criteria for considering studies for this review

Types of studies

Randomized controlled trials (RCTs) and quasi‐RCTs of parallel‐group design, with individuals or clusters as the unit of randomization. Due to the nature of our comparator interventions, we did not find cross‐over trials. In future updates of this review, should there be eligible RCTs with a cross‐over design, we will include data only from the first period for each arm to avoid risk of contamination. Please refer to Table 4 and to our protocol, Morgan 2017, for a full report of methods archived for use in future updates.

1. Methods planned in the protocol but not used in this review.

Topic	Method
Unit of analysis issues	Cluster‐randomized trials We will then combine the estimates and their corrected SEs from the cluster‐randomized trial with those from trials of parallel‐group design using the generic inverse variance method in Review Manager 2014
Dealing with missing data	For interventions in which there is substantial attrition (≥ 15% for at least 1 of the groups) of trial participants (caregivers, children, or caregiver‐child units), we will report the attrition rate and perform sensitivity analyses (see "Sensitivity analysis")
Assessment of heterogeneity	If we identify unexplained heterogeneity, we will not pool results into an overall effect estimate but instead will present the individual effect sizes per study for the specific outcome, in a table
Assessment of reporting biases	If we have 10 or more studies included for an outcome, we will use funnel plots to assess the possibility of small‐study effects. In the case of asymmetry, we will consider various explanations such as publication bias, poor study design, and the effect of study size
Subgroup analysis and investigation of heterogeneity	When data allow, we will perform the subgroup analyses listed below, to explore substantial and considerable heterogeneity across studies Age (e.g. 2 to 5 years of age vs 6 to 12 years of age vs 13 to 18 years of age) High‐income countries or settings vs low‐ and middle‐income countries or settings (according to the World Bank country and lending group classifications [data.worldbank.org/about/country‐and‐lending‐groups] per the year of publication). If there is a multicenter study with sites in countries classified in different income categories, we will consider the study in a subgroup of its own in the meta‐analysis Active caregiver interventions vs inactive caregiver interventions Duration or intensity of intervention (e.g. short term vs long term, one‐off vs multiple sessions) Individual context vs group context (i.e. children receive the intervention individually and with a caregiver vs children receive the intervention in a group and with caregivers) Diet only vs physical activity only vs both behaviors BCT cluster vs no BCT cluster (e.g. techniques from "reward and threat" cluster vs no techniques from "reward and threat" cluster)
Sensitivity analyses	When data allow, we will perform sensitivity analyses to assess the following, and will report results in tables Influence of studies’ risk of bias (first pool all relevant studies per outcome, then pool only studies where the random allocation sequence was appropriately concealed) Influence of attrition (first pool all relevant studies per outcome, then pool only studies where there was less than 15% total attrition or less than 10% differential attrition) Study design (first pool all relevant studies per outcome, then pool only individually randomized trials and cluster‐RCTs where the primary trial authors appropriately adjusted for clustering in their analyses, i.e. cluster‐RCTs where we did not have to calculate effective sample size)

Dietary behavior change interventions with a caregiver component compared to interventions without a caregiver component for improving children's dietary intake
Patient or population: children aged 7 to 18 years  Setting: child + caregiver arm: home and school; child‐only arm: school  Intervention: dietary behavior change interventions with a caregiver component  Comparison: dietary behavior change Interventions without a caregiver component
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No. of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Outcomes	Assumed risk—dietary behavior change Interventions without a caregiver component	Corresponding risk—dietary behavior change interventions with a caregiver component	Relative effect  (95% CI)	No. of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Percentage of children's total energy intake from saturated fat Measured by food record Assessed at end of intervention (9 months)	Mean percentage of total energy from saturated fat in the control group was 14.29%	Mean percentage of total energy from saturated fat in the intervention group was 0.42% lower (1.25 lower to 0.41 higher)	‐	207  (1 RCT)	⊕⊕⊝⊝  Low^a,b	WHO recommends that intake of saturated fat is less than 10% of total energy intake (WHO 2018)
Children's sodium intake (g/d) measured by food record Assessed at end of intervention (9 months)	Mean sodium intake in the control group was 2.2 g/d	Mean sodium intake in the intervention group was 0.12 g/d less (0.36 less to 0.12 more)	‐	207  (1 RCT)	⊕⊕⊝⊝  Low^a,b	WHO recommends that adults consume less than 2 grams of sodium per day. This estimate should be adjusted downward for children based on their energy requirements (WHO 2018)
Children's fruit and vegetable intake (not measured)	‐	‐	‐	‐	‐	No studies reported data for children's combined fruit and vegetable intake
Children's SSB intake (not measured)	‐	‐	‐	‐	‐	No studies reported data for children's SSB intake
Children's total physical activity (not measured)	‐	‐	‐	‐	‐	No studies reported data for children's total physical activity
Children's MVPA (not measured)	‐	‐	‐	‐	‐	No studies reported data for children's MVPA
Adverse effects (not measured)	‐	‐	‐	‐	‐	No studies reported data for adverse effects
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: confidence interval; MVPA: moderate to vigorous physical activity; RCT: randomized controlled trial; SSB: sugar‐sweetened beverage; WHO: World Health Organization.
GRADE Working Group grades of evidence.  High quality: we are very confident that the true effect lies close to that of the estimate of the effect.  Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.  Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.  Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Combined dietary and physical activity interventions with a caregiver component compared to interventions without a caregiver component for improving children's dietary intake and physical activity behaviors
Patient or population: children aged 4 to 14 years  Setting: child + caregiver arm: home, school, not reported; child‐only arm: school, community  Intervention: combined dietary and physical activity interventions with a caregiver component  Comparison: combined dietary and physical activity interventions without a caregiver component
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No. of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Outcomes	Assumed risk—combined dietary and physical activity interventions without a caregiver component	Corresponding risk—combined dietary and physical activity interventions with a caregiver component	Relative effect  (95% CI)	No. of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Children's percentage of total energy intake from saturated fat Measured by food frequency questionnaire and 24‐hour recall Follow‐up: end of intervention (9 months)	Mean percentage of total energy intake from saturated fat in the control group was 10.34%	Mean percentage of total energy intake from saturated fat in the intervention groups was0.06% higher (0.67 lower to 0.80 higher)	‐	216  (2 RCTs)	⊕⊝⊝⊝  Very low^a,b,c	WHO recommends that intake of saturated fat is less than 10% of total energy intake (WHO 2018)
Children's sodium intake (mg/d) Measured by 24‐hour recall Follow‐up: end of intervention (2.5 months and 2.5 years)	Mean sodium intake in the control group was 3112.11 mg/d	Mean sodium intake in the intervention group was 35.94 mg/d more (322.60 fewer to 394.47 more)	‐	315  (2 RCTs)	⊕⊝⊝⊝  Very low^a,b,c	WHO recommends that adults consume less than 2 grams of sodium per day. This estimate should be adjusted downward for children based on their energy requirements (WHO 2018)
Children's fruit and vegetable intake (servings/d) Measured by food frequency questionnaire Follow‐up: end of intervention (3 years)	Mean fruit and vegetable intake in the control group was 1.84 servings/d	Mean fruit and vegetable intake in the intervention group was 0.38 servings/d more (0.51 fewer to 1.27 more)	‐	134  (1 RCT)	⊕⊝⊝⊝  Very low^a,c,d	WHO recommends consuming more than 400 grams of fruit and vegetables per day (WHO 2018)
Children's SSB intake (SSB drinks/d, soft drink glasses/d and regular soda servings/d) Measured by questionnaires Follow‐up: end of intervention (9 months, 21 months, and 3 years)	‐	Mean SSB intake in the intervention group was 0.28 standard deviations lower (0.44 lower to 0.12 lower)	‐	651  (3 RCTs)	⊕⊕⊕⊝  Moderate^a	WHO recommends reducing consumption of SSB. The recommendation for intake of free sugars is less than 10% of total energy intake (WHO 2018) The observed standard deviation of 0.28 probably represents a small, significant difference between arms
Children's total physical activity (min/d) Measured by questionnaires Follow‐up: end of intervention (21 months and 2.5 years)	Mean total physical activity score in the control group was 135.54 min/d	Mean total physical activity score in the intervention group was 1.81 min/d more (15.18 less to 18.8 more)	‐	573  (2 RCTs)	⊕⊕⊝⊝  Low^a,c	WHO recommends that physical activity beyond 60 minutes of MVPA per day provides additional benefits (WHO 2010)
Children's MVPA (min/d) Measured by questionnaire Follow‐up: end of intervention (2.5 years)	Mean MVPA score in the control group was 123.97 min/d	Mean MVPA score in the intervention group was 0.05 min/d less (18.57 less to 18.47 more)	‐	622  (1 RCT)	⊕⊝⊝⊝  Very low^a,c,d	WHO recommends that youth aged 5 to 17 years should do at least 60 minutes of MVPA daily (WHO 2010)
Adverse effects (not reported by intervention arm)	‐	‐	‐	‐	‐	No studies reported data for adverse effects by intervention arm
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: confidence interval; MVPA: moderate to vigorous physical activity; RCT: randomized controlled trial; SSB: sugar‐sweetened beverage; WHO: World Health Organization.
GRADE Working Group grades of evidence.  High quality: we are very confident that the true effect lies close to that of the estimate of the effect.  Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.  Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.  Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Children's dietary intake—total energy intake (kcal/d): end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2 Children's dietary intake—percentage energy intake from fat: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3 Children's dietary intake—percentage energy intake from saturated fat: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4 Children's dietary intake—percentage energy intake from protein: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5 Children's dietary intake—sodium intake (mg/kcal): follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6 Children's dietary intake—sodium intake (g/d): end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7 Children's dietary intake—fruit intake: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
8 Children's dietary intake—fruit intake: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
9 Children's dietary intake—vegetable intake: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
10 Children's dietary intake—vegetable intake: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
11 Children's body mass index or weight‐for‐height parameter—body mass index (value or percentile): end of intervention	2	313	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.31, 0.14]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Children's physical activity levels—total physical activity: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2 Children's physical activity levels—moderate to vigorous physical activity: end of intervention (change values)	2	80	Std. Mean Difference (IV, Random, 95% CI)	0.04 [‐0.41, 0.49]
3 Children's physical activity levels—moderate to vigorous physical activity: end of intervention (end values)	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4 Children's physical activity levels—moderate to vigorous physical activity: all intervention time points	3		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.1 < 3 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 ≥ 3 to ≤ 6 months	3		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Children's physical activity levels—moderate to vigorous physical activity: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6 Children's physical activity levels—moderate physical activity: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7 Children's physical activity levels—vigorous physical activity: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
8 Children's physical activity levels—light physical activity: end of intervention	2	80	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.97, 0.24]
9 Children's physical activity levels—light physical activity: all intervention time points	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
9.1 < 3 months	1	26	Std. Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.81, 0.74]
9.2 ≥ 3 to ≤ 6 months	2	80	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.97, 0.24]
10 Children's physical activity levels—steps: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
11 Children's physical activity levels—total physical activity score: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
12 Children's sedentary behavior—sedentary behavior: end of intervention (change values)	2	80	Std. Mean Difference (IV, Random, 95% CI)	0.26 [‐0.47, 0.98]
13 Children's sedentary behavior—sedentary behavior: end of intervention (end values)	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
14 Children's sedentary behavior—sedentary behavior: all intervention time points	3		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
14.1 < 3 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.2 ≥ 3 to ≤ 6 months	3		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Children's sedentary behavior—sedentary behavior: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
16 Children's body mass index or weight‐for‐height parameter—body mass index: end of intervention	2	441	Mean Difference (IV, Random, 95% CI)	0.07 [‐0.21, 0.35]
17 Children's body mass index or weight‐for‐height parameter—body mass index: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
18 Caregivers' physical activity levels—total physical activity score: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
19 Caregiver's physical activity levels—moderate to vigorous physical activity: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
20 Caregiver's physical activity levels—moderate to vigorous physical activity: all intervention time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
20.1 < 3 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
20.2 ≥ 3 to ≤ 6 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
21 Caregiver's physical activity levels—light physical activity: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
22 Caregiver's physical activity levels—light physical activity: all intervention time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
22.1 < 3 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
22.2 ≥ 3 to ≤ 6 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Children's dietary intake—total energy intake: end of intervention	3	440	Mean Difference (IV, Random, 95% CI)	14.45 [‐117.20, 146.10]
2 Children's dietary intake—total energy intake: all intervention time points	3		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2.1 < 3 months	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.4 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Children's dietary intake—total energy intake: follow‐up time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4 Children's dietary intake—percentage energy from fat: end of intervention	4	563	Mean Difference (IV, Random, 95% CI)	1.17 [‐0.65, 3.00]
5 Children's dietary intake—percentage energy from fat: all intervention time points	4		Mean Difference (IV, Random, 95% CI)	Subtotals only
5.1 < 3 months	1	70	Mean Difference (IV, Random, 95% CI)	0.17 [‐3.87, 4.21]
5.2 > 6 months to ≤ 1 year	2	405	Mean Difference (IV, Random, 95% CI)	0.58 [‐2.14, 3.30]
5.3 > 1 year to ≤ 2 years	1	283	Mean Difference (IV, Random, 95% CI)	3.12 [‐0.79, 7.03]
5.4 > 2 years to ≤ 3 years	1	151	Mean Difference (IV, Random, 95% CI)	0.45 [‐2.49, 3.39]
6 Children's dietary intake—percentage energy from fat: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7 Children's dietary intake—percentage energy from saturated fat: end of intervention (includes all intervention time points)	2	216	Mean Difference (IV, Random, 95% CI)	0.06 [‐0.67, 0.80]
7.1 > 6 months to ≤ 1 year	1	59	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.75, 0.95]
7.2 > 2 years to ≤ 3 years	1	157	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐1.46, 1.38]
8 Children's dietary intake—percentage energy from saturated fat: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
9 Children's dietary intake—percentage energy from carbohydrates: end of intervention (includes all intervention time points)	2	266	Mean Difference (IV, Random, 95% CI)	‐0.88 [‐3.49, 1.74]
9.1 < 3 months	1	70	Mean Difference (IV, Random, 95% CI)	‐0.92 [‐5.73, 3.89]
9.2 > 2 years to ≤ 3 years	1	196	Mean Difference (IV, Random, 95% CI)	‐0.86 [‐3.98, 2.26]
10 Children's dietary intake—percentage energy from carbohydrates: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
11 Children's dietary intake—percentage energy from protein: end of intervention (includes all intervention time points)	2	241	Mean Difference (IV, Random, 95% CI)	0.45 [‐0.80, 1.69]
11.1 < 3 months	1	70	Mean Difference (IV, Random, 95% CI)	0.77 [‐1.66, 3.20]
11.2 > 2 years to ≤ 3 years	1	171	Mean Difference (IV, Random, 95% CI)	0.33 [‐1.12, 1.78]
12 Children's dietary intake—percentage energy from protein: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
13 Children's dietary intake—sodium intake: end of intervention (includes all intervention time points)	2	315	Mean Difference (IV, Random, 95% CI)	35.94 [‐322.60, 394.47]
13.1 < 3 months	1	70	Mean Difference (IV, Random, 95% CI)	70.27 [‐743.71, 884.25]
13.2 > 2 to ≤ 3 years	1	245	Mean Difference (IV, Random, 95% CI)	27.67 [‐371.70, 427.04]
14 Children's dietary intake—sodium intake: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
15 Children's dietary intake—fruit and vegetable intake: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
16 Children's dietary intake—fruit and vegetable intake: all intervention time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
16.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
16.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
16.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
17 Children's dietary intake—fruit intake: end of intervention	2	417	Std. Mean Difference (IV, Random, 95% CI)	0.23 [0.03, 0.43]
18 Children's dietary intake—fruit intake: all intervention time points	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
18.1 > 6 months to ≤ 1 year	2	483	Std. Mean Difference (IV, Random, 95% CI)	0.19 [0.01, 0.38]
18.2 > 1 year to ≤ 2 years	1	358	Std. Mean Difference (IV, Random, 95% CI)	0.10 [‐0.11, 0.31]
19 Children's dietary intake—vegetable intake: end of intervention (includes all intervention time points)	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
20 Children's dietary intake—sugar‐sweetened beverage intake: end of intervention	3	651	Std. Mean Difference (IV, Random, 95% CI)	‐0.28 [‐0.44, ‐0.12]
21 Children's dietary intake—sugar‐sweetened beverage intake: all intervention time points	3		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
21.1 > 6 months to ≤ 1 year	3	799	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.39, ‐0.11]
21.2 > 1 year to ≤ 2 years	2	630	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.45, 0.03]
21.3 > 2 years to ≤ 3 years	1	134	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.58, 0.12]
22 Children's dietary intake—water intake: end of intervention	3	600	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.24, 0.09]
23 Children's dietary intake—water intake: all intervention time points	3		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
23.1 > 6 months to ≤ 1 year	2	610	Std. Mean Difference (IV, Random, 95% CI)	0.06 [‐0.10, 0.22]
23.2 > 1 year to ≤ 2 years	2	518	Std. Mean Difference (IV, Random, 95% CI)	0.03 [‐0.15, 0.20]
23.3 > 2 years to ≤ 3 years	2	254	Std. Mean Difference (IV, Random, 95% CI)	‐0.18 [‐0.43, 0.07]
24 Children's physical activity levels—total physical activity: end of intervention	2	573	Mean Difference (IV, Random, 95% CI)	1.81 [‐15.18, 18.80]
25 Children's physical activity levels—total physical activity: all intervention time points	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
25.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
25.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
25.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
26 Children's physical activity levels—total physical activity: follow‐up time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
26.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
26.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
26.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
27 Children's physical activity levels—moderate to vigorous physical activity: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
28 Children's physical activity levels—moderate to vigorous physical activity: all intervention time points	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
28.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
28.2 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
29 Children's physical activity levels—moderate to vigorous physical activity: follow‐up time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
29.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
29.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
29.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
30 Children's physical activity levels—light physical activity: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
31 Children's physical activity levels—light physical activity: all intervention time points	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
31.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
31.2 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
32 Children's physical activity levels—light physical activity: follow‐up time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
32.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
32.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
32.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
33 Children's physical activity levels—weight‐bearing physical activity: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
34 Children's physical activity levels—steps: end of intervention	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
35 Children's physical activity levels—steps: all intervention time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
35.1 1 week	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
35.2 2 weeks	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
35.3 3 weeks	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
35.4 4 weeks	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
36 Children's sedentary behavior—sedentary behavior: end of intervention (includes all intervention time points)	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
37 Children's sedentary behavior—sedentary behavior: follow‐up time points	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
37.1 > 6 months to ≤ 1 year	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
37.2 > 1 year to ≤ 2 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
37.3 > 2 years to ≤ 3 years	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
38 Prevalence of overweight and obesity among children—prevalence: end of intervention	3	1866	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.89, 1.17]
39 Prevalence of overweight and obesity among children—prevalence: all intervention time points	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
39.1 > 6 months to ≤ 1 year	2	641	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.80, 1.30]
39.2 > 1 year to ≤ 2 years	2	590	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.76, 1.27]
39.3 > 2 years to ≤ 3 years	2	1448	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.88, 1.18]
40 Prevalence of overweight and obesity among children—prevalence: follow‐up time point	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
41 Children's body mass index or weight‐for‐height parameter—body mass index: end of intervention	4	1861	Std. Mean Difference (IV, Random, 95% CI)	0.05 [‐0.04, 0.15]
42 Children's body mass index or weight‐for‐height parameter—body mass index: all intervention time points	4		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
42.1 < 3 months	1	72	Std. Mean Difference (IV, Random, 95% CI)	0.20 [‐0.26, 0.66]
42.2 > 6 months to ≤ 1 year	2	612	Std. Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.17, 0.15]
42.3 > 1 year to ≤ 2 years	2	517	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.21, 0.14]
42.4 > 2 years to ≤ 3 years	2	1444	Std. Mean Difference (IV, Random, 95% CI)	0.07 [‐0.03, 0.18]
43 Children's body mass index or weight‐for‐height parameter—body mass index: follow‐up time point	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Methods	Study design: randomized controlled trial Study grouping: parallel group Study aim: "...to examine the feasibility and efficacy of a 12‐week culturally tailored mother‐daughter PA intervention on the PA levels of pre‐adolescent African‐American girls" (quote) Study period: study start date: January 2013; primary completion date: August 2014 Total number of arms: 3 Description of intervention arms: 1. Dancing intervention with mother involvement (child + caregiver); 2. Dancing intervention alone (child‐only); 3. No‐intervention comparison group (not eligible) Sample size justification and outcome used: "the sample size and power calculation were based on a three‐group model in which we examined differences in rate‐of‐change in percent of time spent in MVPA between any two groups over 12 weeks" (quote). The sample size calculation was based on the Stanford GEMS pilot study and baseline data from the GEMS 2‐year intervention. To detect a difference between 20 and 50 minutes of MVPA per day between any 2 groups, with 80% power and an alpha level of 0.05, approximately 20 dyads per arm (60 overall) were needed Unit of allocation: mother‐daughter dyad Missing data handling: hierarchical linear modeling (HLM) software was used, which "accommodates for missing data, retaining participants who contribute data for at least one‐time point for the dependent variable" (quote) Reported limitations: 1. Small sample size due to high attrition rates; 2. Attrition rate highest among control group participants (non‐uniform attrition); 3. No transportation provided for participants; 4. Intervention did not directly target the home environment Randomization ratio and stratification: 1:1:1; stratified by girls' BMI percentile (≥ 85th percentile, < 85th percentile) Participant compensation or incentives: not reported
Participants	Baseline characteristics Child + caregiver arm (intervention group) Female (PROGRESS‐Plus): n (%): 28/28 (100) Age in years (PROGRESS‐Plus): mean (SD): 8.8 (1.4) Race/ethnicity/language/culture (PROGRESS‐Plus): African American or Black, n (%): 28/28 (100) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): high school or less, n (%): 6 (23.1); some college/technical school, n (%): 14 (53.8); college graduate, n (%): 6 (23.1) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): annual household income < United States dollar (USD) 20,000, n (%): 8 (29.6); USD 20,000 to 39,000, n (%): 10 (37.0); USD 40,000 to 59,000, n (%): 4 (14.8); > USD 59,000, n (%): 5 (18.5) Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: BMI percentile, mean (SD): 73.3 (28.9) Child diet: not reported Child physical activity: % time spent in MVPA, mean (SD): 2.9 (2.0); % time spent in LPA, mean (SD): 36.5 (7.7); % time spent in sedentary behavior, mean (SD): 60.5 (9.2) Caregiver weight status: BMI (kg/m²), mean (SD): 34.0 (7.4) Caregiver diet: not reported Caregiver physical activity: % time spent in MVPA, mean (SD): 1.6 (0.9); % time spent in LPA, mean (SD): 27.1 (6.9); % time spent in sedentary behavior, mean (SD): 71.7 (7.3) Caregiver civil status (PROGRESS‐Plus): single‐never married, mean (%): 19 (70.4); married, n (%): 6 (22.2); divorced/separated/widowed, n (%): 2 (7.4) Child‐only arm (control group) Female (PROGRESS‐Plus): n (%): 25/25 (100) Age in years (PROGRESS‐Plus): mean (SD): 7.8 (1.0) Race/ethnicity/language/culture (PROGRESS‐Plus): African American or Black, n (%): 25/25 (100) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): high school or less, n (%): 8 (38.1); some college/technical school, n (%): 4 (19.0); college graduate, n (%): 9 (42.9) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): annual household income < USD 20,000, n (%): 8 (36.4); USD 20,000 to 39,000, n (%): 6 (27.3); USD 40,000 to 59,000, n (%): 7 (31.8); > USD 59,000, n (%): 1 (4.6) Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: BMI percentile, mean (SD): 60.1 (30.9) Child diet: not reported Child physical activity: % time spent in MVPA, mean (SD): 2.5 (2.0); % time spent in LPA, mean (SD): 34.3 (7.2); % time spent in sedentary behavior, mean (SD): 63.1 (8.2) Caregiver weight status: BMI (kg/m²), mean (SD): 29.9 (7.3) Caregiver diet: not reported Caregiver physical activity: % time spent in MVPA, mean (SD): 1.5 (0.8); % time spent in LPA, mean (SD): 28.8 (5.4); % time spent in sedentary behavior, mean (SD): 69.8 (5.9) Caregiver civil status (PROGRESS‐Plus): single‐never married, mean (%): 14 (60.9); married, n (%): 6 (26.1); divorced/separated/widowed, n (%): 3 (13.0) Recruitment methods: participants were recruited via flyers, radio announcements, and face‐to‐face recruitment. Eligible children and mothers were asked to provide written assent or informed consent upon enrollment into the study Inclusion criteria: child: female and 7 to 11 years old on the date of randomization, identified by her mother as African American or Black; mother: self‐defined as African American or Black and defined herself as the primary maternal figure that resided with the child Exclusion criteria: participant: child had any condition limiting her ability to participate in the physical activity intervention or in the assessment of physical activity, child had any medical condition that limited growth or took any medications affecting growth, or the girl or mother were unable to read and complete the informed consent in English Age of participating children at baseline: 7 to 11 years Total number randomized by relevant group: total across all study arms: n = 76; child + caregiver arm: n = 28; child‐only arm: n = 25 Baseline imbalances between relevant groups: significant between‐group baseline differences were observed for girls' age (P = 0.02) and for mothers' marital status (P = 0.002) and for education level (P = 0.04) Total number analyzed by relevant group: total across all study arms: n = 32; child + caregiver arm: n = 14; child‐only arm: n = 12 Attrition by relevant group: child + caregiver arm: 50.0% (14/28); child‐only arm: 48.0% (12/25) Description of sample for baseline characteristics reported above: consented children and mothers (child + caregiver arm: n = 28; child‐only arm: n = 25)
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): after‐school culturally tailored dance intervention for girls and their mothers Focus of intervention: physical activity Behavior change techniques: in addition to the child‐only intervention, the following techniques were applied separately or differently in the child + caregiver arm: "social support," "shaping knowledge," "comparison of behavior," "repetition and substitution," and "comparison of outcomes" Why: rationale, theory, or goal (TIDieR #2): social cognitive theory—which underpins this intervention—suggests that behavior is learned in part through modeling and observing peers and role models, such as mothers. Despite the key role African American mothers are thought to play in influencing their daughters' physical activity levels, previous physical activity interventions for girls have minimally involved mothers. This intervention aimed to examine the feasibility and efficacy of a mother‐daughter physical activity intervention How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only intervention, mothers were invited to participate with their daughters in the dance classes 3 times per week throughout the 12‐week intervention. As with the child‐only arm, girls received cultural lessons for 15 minutes per week, and mothers and daughters received weekly newsletters Who: providers (TIDieR #5): same as child‐only arm Economic variables and resources required for replication: not reported Strategies to address disadvantage: same as child‐only arm Subgroups: not reported Assessment time points: baseline, 6 weeks, 12 weeks (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): same as child‐only arm, except that mothers additionally participated in the dance classes Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): as with the child‐only arm, intervention fidelity was high (> 95%) across most components, except cultural lesson integration (60.9%). During most classes (> 90%), at least 50% of girls and mothers actively participated and seemed to be having fun. Participation rates were quite low, with an average of 7.0 ± 2.0 girls and 5.1 ± 2.6 mothers attending each class. During the dance classes, girls spent an average of 9.1 ± 12.9 minutes in sedentary behavior, 34.1 ± 12.0 minutes in LPA, and 10.8 ± 8.8 minutes in MVPA. All newsletters were sent out Sensitivity analyses: not reported Child‐only arm (control group) Brief name/description (TIDieR #1): after‐school culturally tailored dance intervention for girls Focus of intervention: physical activity Behavior change techniques: ''shaping knowledge," "comparison of behavior," "repetition and substitution," and "comparison of outcomes" Why: rationale, theory, or goal (TIDieR #2): African American girls experience higher rates of obesity and physical inactivity than Caucasian girls. Thus, interventions to support and encourage physical activity among African American girls are needed. The MAGNET intervention was based on social cognitive theory and incorporated African American cultural influences (e.g. dance and music styles) How, where, and when and how much (TIDieR #6 to 8): girls participated in after‐school sessions 3 days per week for 12 weeks. Each session consisted of 2 hours of a healthy snack and homework tutoring and 1 hour of the dance intervention. Girls also received cultural lessons (15 minutes) and a health newsletter once per week. Mothers participated in weekly health education lessons and received health newsletters Who: providers (TIDieR #5): dance classes were taught by experienced African American female dance instructors, and the education curriculum was taught by the research staff Economic variables and resources required for replication: not reported Strategies to address disadvantage: intervention focused on African American girls Subgroups: not reported Assessment time points: baseline, 6 weeks, 12 weeks (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): the dance intervention consisted of 6 routines developed by professional dancers (1 African dance routines, 2 Jazz routines, and 2 Hip Hop routines). Each routine consisted of a 2‐minute warm‐up, 8 minutes of moderate to vigorous dance movements, and a 1‐minute cool‐down. Each dance style was accompanied by educational materials that highlighted the history of the style and its impact on African culture. Newsletters used "educational materials from federal health agencies on topics relevant to African‐American communities" (quote). Newsletters for mothers and daughters covered the same content, but those for daughters additionally contained activities to complete and highlighted the impact of historical African American female figures Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): intervention fidelity was high (> 95%) across most components (routines, music, encouragement), with the exception of integrating cultural lessons into dance classes (57.8%). During most classes (> 95%), at least 50% of the girls actively participated and seemed to be having fun. Participation rates were quite low, with an average of 6.2 ± 2.9 girls attending each class. During the dance classes, girls spent an average of 6.4 ± 8.7 minutes in sedentary behavior, 41.4 ± 9.3 minutes in LPA, and 11.1 ± 8.5 minutes in MVPA. All newsletters were sent out Sensitivity analyses: not reported
Outcomes	The following instruments were used to measure outcomes relevant to this review at baseline, 6 weeks, and 12 weeks (end of intervention) Children's and caregivers' physical activity levels and children's sedentary behavior: Actigraph accelerometer (Actigraph LLC, Pensacola, Florida, USA); a valid wear day consisted of at least 480 minutes of wear time on at least 3 days, including 1 weekend day, over a 7‐day period. Percentage of time spent in all activity intensities and sedentary behavior between 8:00 am and 10:00 pm was determined using established cut points Available data from midpoint and end‐of‐intervention assessments include MVPA, light physical activity, and sedentary time Authors calculated changes in children's vigorous physical activity, but data on this variable were not reported and could not be retrieved In addition to physical activity and sedentary time measures for the whole day, the study authors calculated physical activity and time spent in sedentary behavior during after‐school hours. We determined these measures to be ineligible as they do not fully capture activity levels or sedentary behavior Children's anthropometry: height measured with portable stadiometer and weight measured with digital scale (specific instruments not reported) BMI percentiles were calculated using the CDC growth charts, but data were not reported for either assessment and could not be retrieved from the study authors Prevalence of overweight and obesity was not reported for either assessment and could not be retrieved from the study authors
Identification	Study name: Mothers And dauGhters daNcing togEther Trial (MAGNET) Country: USA Setting: elementary school in Springfield, Massachusetts Types of reports: published protocol; published journal article; trial registration Comments: used the following reports: (1) Alhassan 2018; (2) Burkart 2017; (3) Trial registration (NCT01588379) Author's name: Sofiya Alhassan Email: alhassan@kin.umass.edu Conflicts of interest: "Authors have no conflict of interest to report" (quote) Sponsorship source: Canadian Institutes of Health Research (CIHR)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation	Unclear risk	Judgment comment: insufficient information to permit judgment
Allocation concealment	Unclear risk	Judgment comment: methods to conceal the allocation sequence were not described
Blinding of participants and personnel   All outcomes	Unclear risk	Judgment comment: no blinding was done. Given that children were aged 7 to 10 years, their performance was not likely to have been influenced by lack of blinding. However, outcomes related to the caregivers may or may not have been influenced by lack of blinding
Blinding of outcome assessment   All outcomes	Unclear risk	Judgment comment: no information was provided on blinding of outcome assessors. Height and weight were measured. Physical activity was assessed by accelerometer. BMI may or may not have been influenced by lack of blinding
Incomplete outcome data   All outcomes	High risk	Judgment comment: we calculated attrition rates by dividing the number of dropouts by the number of children participating at baseline. Total attrition at 12 weeks (end of intervention) was 57.9% (44/76) for the study overall and 50.9% (27/53) for the 2 relevant study arms. Differential attrition for the 2 relevant study arms was 2.0% (14/28 vs 13/25)
Selective reporting	High risk	Judgment comment: the trial was registered and expected outcomes pre‐specified. However, study authors reported in the Abstract that vigorous physical activity was measured, but results for these were not reported in the Results section. Also, in the trial registry entry, study authors pre‐specified BMI as a secondary outcome, but results for this were not reported in the article
Recruitment bias	Low risk	Judgment comment: not relevant. This was an individually randomized trial
Baseline imbalance	Low risk	Judgment comment: not relevant. This was an individually randomized trial
Loss of clusters	Low risk	Judgment comment: not relevant. This was an individually randomized trial
Incorrect analysis	Low risk	Judgment comment: not relevant. This was an individually randomized trial
Comparability with individually randomized trials	Low risk	Judgment comment: not relevant. This was an individually randomized trial
Other sources of bias	High risk	Judgment comment: significant differences in mothers' BMI, income, and marital status (measured at baseline) were observed between dyads that dropped out and those with complete data

Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "... to evaluate the effectiveness of intervention approaches aimed at incorporating parental participation and increasing parents' knowledge and practice in delivering a healthy diet and more opportunities for physical activity to their children" (quote) Study period: 4 weeks during the 2003‐2004 school year Total number of arms: 2 Description of intervention arms: 1. Child and parental participation (child + caregiver); 2. Child participation only (child only) Number of clusters per arm: child + caregiver arm: n = 14; child‐only arm: n = 15 Average cluster size: 15.07 children Sample size justification and outcome used: not reported Unit of allocation: schools Missing data handling: participants with missing data were excluded from analyses Reported limitations: 1. Only about half of all families screened returned a baseline questionnaire; 2. Some outcomes were reported by caregivers; 3. Screening was made available to all kindergarten students, but the findings are based on a convenience sample; and 4. The intervention was short term (4 weeks) Randomization ratio and stratification: ˜ 1:1; stratification not reported Participant compensation or incentives: not reported
Participants	Baseline characteristics Child + caregiver arm (Intervention group) Female (PROGRESS‐Plus): n (%): 13/24 (54.2) Age in years (PROGRESS‐Plus): mean (SD): 5 (0.47) Race/ethnicity/language/culture (PROGRESS‐Plus): white, n (%): 24/24 (100) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): years, mean (SD): 15.4 (5.3) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): not reported Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: prevalence of overweight or obesity, n (%): 6/24 (33.4) Child diet: not reported Child physical activity: not reported Caregiver weight status: not reported Caregiver diet: not reported Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): not reported Child‐only arm (control group) Female (PROGRESS‐Plus): n (%): 15/26 (57.7) Age in years (PROGRESS‐Plus): mean (SD): 5 (0.45) Race/ethnicity/language/culture (PROGRESS‐Plus): white, n (%): 26/26 (100) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): years, mean (SD): 14.2 (2.1) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): not reported Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: prevalence of overweight or obesity, n (%): 7/26 (26.9) Child diet: not reported Child physical activity: not reported Caregiver weight status: not reported Caregiver diet: not reported Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): not reported Although not reporting by intervention arm, the study authors do provide additional information on the overall study sample Child diet: average number of servings of fruit consumed weekly (SD): 8.5 (6.2); average number of servings of vegetables consumed weekly (SD): 9.2 (6.0) (children with baseline questionnaire, n = 203) Caregiver civil status (PROGRESS‐Plus): married, n (%): 306/437 (70.1) (screened sample, n = 437) Recruitment methods: 4 rural counties out of 10 in West Virginia, whose staff indicated interest in rural health and education, were randomly chosen and invited to participate. It is unclear whether the 29 schools that were randomized were the total number of schools within these counties, or whether a proportion of schools were recruited. A short description of the program was provided to teachers and children, and then a booklet consisting of a caregiver consent form and the screening intake form was sent home with the children Inclusion criteria: cluster: school located in 1 of 4 randomly chosen rural counties; participants: children enrolled in kindergarten (aged 4 to 6 years) and caregivers Exclusion criteria: not reported Age of participating children at baseline: 4 to 6 years (kindergarten) Total number randomized by relevant group: total across both study arms: n = 437. Samples per arm were not reported and therefore were estimated: child + caregiver arm: n = 219; child‐only arm: n = 219 Baseline imbalances between relevant groups: baseline characteristics not reported by study arm Total number analyzed by relevant group: child + caregiver arm: n = 24; child‐only arm: n = 26 Attrition by relevant group: attrition was not reported and cannot be calculated because study authors did not report the number of children by intervention arm at baseline Description of sample for baseline characteristics reported above: children included in the analysis (child + caregiver arm: n = 24; child‐only arm: n = 26)
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): pedometer and step log for child and caregiver plus evidence‐based diet and physical activity information and—for families with a child with a BMI ≥ 85th percentile—information on ways to reduce energy intake Focus of intervention: physical activity and diet Behavior change techniques: in addition to the child‐only arm, the following techniques were applied separately or differently in the child + caregiver arm: "feedback and monitoring," "shaping knowledge," "natural consequences," and "antecedents" Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): same as child‐only arm, except that caregivers also received a pedometer and a daily step log. The intervention lasted 4 weeks Who: providers (TIDieR #5): same as child‐only arm Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 4 weeks (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): each child and her/his participating caregiver were given the NEO Walkin’ Buddy Walk4Life Step Only pedometer and a daily step log to record each participant’s steps. Families received obesity prevention information packets that differed from those provided to families in the child‐only arm. Content included health information and information on ways to increase exercise, particularly steps. Caregivers of overweight and obese children also received information on ways to reduce energy intake Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): same as child‐only arm Sensitivity analyses: not reported Child‐only arm (control group) Brief name/description (TIDieR #1): pedometer and step log for child plus information for families on age‐appropriate diet and physical activity guidelines Focus of intervention: physical activity and diet Behavior change techniques: "feedback and monitoring," "shaping knowledge," and "antecedents" Why: rationale, theory, or goal (TIDieR #2): educating children on issues related to healthy lifestyles and obesity may support behavior change. However, school interventions target only a portion of children’s time, suggesting a benefit for involving caregivers. The study authors did not describe the use of theory in development of this intervention How, where, and when and how much (TIDieR #6 to 8): following receipt of consent and a completed screening intake form, children’s height and weight were measured to calculate BMI. Caregivers were mailed results of the child's screening and asked further questions, which they had to return via mail to project staff (via postage‐paid envelopes). Upon receipt of completed questionnaires, caregivers received age‐appropriate information about diet and exercise guidelines, and children received a pedometer and a pedometer step log to be used over a 4‐week period Who: providers (TIDieR #5): staff from West Virginia Rural Health Education Partnership (WVRHEP) and research staff Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 4 weeks (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): each child was given the NEO Walkin’ Buddy Walk4Life Step Only pedometer. Caregivers were instructed to record the total number of steps that their child took each day. Families were also provided with an information packet that included age‐appropriate diet and physical activity guidelines for kindergarten children Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): following completion of the study, a 10‐item process evaluation form was given to each caregiver to identify strengths and weaknesses of study procedures and materials. Thirty‐seven participants returned post‐intervention process evaluations. Data for both study arms were presented together. Over half of participants (23/37; 62.2%) reported that their children always wore their pedometers during the study. Most caregivers (35/37; 94.9%) reported that they read the information about diet, physical activity, and BMI calculations for young children at least once during the study period. Barriers to completing the study included having little time to record steps, decreasing the novelty of using pedometers, and navigating family dynamics in which not all children were given pedometers. Strengths included encouraging increased physical activity and family interaction and learning new things Sensitivity analyses: not reported
Outcomes	The following instruments were used to measure outcomes relevant to this review at baseline and 4 weeks (end of intervention) Children's dietary intake: dietary checklist designed specifically for this study; the study authors reported test‐retest reliability Statistics are provided for fruit intake and vegetable intake but were not extracted due to unclear reporting The following instrument was used to measure outcomes relevant to this review at 1 week, 2 weeks, 3 weeks, and 4 weeks (end of intervention) Children's physical activity levels: NEO Walkin' Buddy Walk4Life Step Only Pedometer Data are available for children's steps each week Children's height and weight were measured at baseline and were used to calculate prevalence of overweight or obesity based on the CDC age‐ and gender‐specific growth charts. However, measurements do not appear to have been repeated at the end of the intervention
Identification	Study name: Coronary Artery Risk Detection in Appalachian Communities (CARDIAC)—Kinder Country: USA Setting: homes in rural West Virginia Types of reports: published journal article Comments: used only one report: Cottrell 2005 Author's name: Lesley Cottrell Email: lcottrell@hsc.wvu.edu Conflicts of interest: not reported Sponsorship source: not reported
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation	Unclear risk	Quote: "randomization was conducted at school level..." (p 357) Judgment comment: the method used to generate the random sequence was not reported
Allocation concealment	Unclear risk	Judgment comment: methods to conceal the allocation sequence were not described
Blinding of participants and personnel   All outcomes	Low risk	Judgment comment: no information on blinding of participants and personnel was provided. However, given the nature of the intervention, there would have been no way to blind participants and personnel. Also, the children were aged 4 to 6 years, so their performance was not likely to have been influenced by lack of blinding
Blinding of outcome assessment   All outcomes	Unclear risk	Judgment comment: no information on blinding of outcome assessors was provided. However, steps were measured by pedometer and are unlikely to have been influenced by lack of blinding. Fruit and vegetable intake was measured by caregiver report and may or may not have been influenced by lack of blinding
Incomplete outcome data   All outcomes	High risk	Judgment comment: attrition rates were not reported and could not be calculated because the study authors did not report the number of children by intervention arm at baseline. However, 88.5% (386/436) of children screened (with consent) and 75.4% (153/203) of children who returned the baseline questionnaire did not have complete data and were excluded from analyses
Selective reporting	High risk	Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Data on child steps were reported in a format that could be entered into meta‐analysis. However, the format in which dietary outcome data were reported lacked clarity, and we could not retrieve the relevant data from study authors. Due to our lack of confidence in the dietary data, we did not extract them
Recruitment bias	High risk	Judgment comment: schools were randomized before recruitment of participants
Baseline imbalance	Unclear risk	Judgment comment: the study authors did not report on similarities and differences between intervention arms or clusters
Loss of clusters	Unclear risk	Judgment comment: loss of clusters was not reported. However, nearly 90% of screened children did not have complete data from the intervention and were excluded from the analysis, so it is possible that some clusters could have been lost
Incorrect analysis	Low risk	Quote: "a repeated measures multivariate analysis of covariance (MANCOVA) was used to evaluate differences between the groups based on children's average steps across the four‐week period while controlling for potential clustering effects related to school enrollment" (p 598)
Comparability with individually randomized trials	Unclear risk	Judgment comment: information was insufficient to permit judgment
Other sources of bias	Low risk	Judgment comment: we detected no other sources of bias

Study	Reason for exclusion
Brannon 2018	Ineligible study design: cross‐over trial without suitable first period data
DeVilliers 2009	Ineligible control: no intervention received
Harrington 2005	Ineligible study design: secondary analyses from a randomized controlled trial
Natale 2016	Ineligible control: did not receive an eligible child‐only intervention
Regev 2012	Ineligible outcomes
Russell Mayhew 2007	Ineligible outcomes
Treu 2017	Ineligible study design: experimental but not random or quasi‐random

Trial name or title	Creating Healthy Habits Among Maryland Preschoolers (CHAMP)
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: this study aims "to evaluate strategies to prevent health disparities by building wellness‐related habits of diet and physical activity into daily child care activities and extending the habits introduced in child care centers to caregivers" (quote) Study period: June 2016 to July 2019 Total number of arms: 3 Description of intervention arms: 1. Child care center−based wellness intervention plus a web‐based caregiver intervention (child + caregiver arm); 2. Child care center−based wellness intervention (child only); 3. No intervention control (not eligible) Number of clusters per arm: not known Average cluster size: not known Sample size justification and outcome used: study authors reported their intent to enroll 864 children across 54 child care centers (an average of 16 children per center). To calculate power and sample size estimates, study authors assumed a correlation of r = 0.5 between repeated measures of the same individual, accounted for a loss to follow‐up rate of 20%, and estimated an ICC of 0.03. Study authors reported that the expected sample size "will provide adequate power (> 0.8) to detect an effect as small as 0.27 standard deviations (SD) across outcomes" (quote). The estimate of intraclass correlation coefficient (ICC) was based on previous literature and was averaged across outcomes of interest (child body mass index, MVPA, fruit and vegetable intake, and willingness to try new foods) Unit of allocation: child care center Missing data handling: not known Reported limitations: not known Randomization ratio and stratification: 1:1:1; research staff matched centers into stratified groups of 3 based on similarity of center size, location, and racial/ethnic mix. Centers within the group of 3 are then randomized to 1 of the 3 conditions Participant compensation or incentives: caregivers and child care staff receive gift card compensation for completion of questionnaires, and caregivers receive additional gift card reimbursement for completion of the secondary measures. Liaisons working at each participating child care center receive gift card compensation for recruiting participants
Participants	Baseline characteristics: not known Recruitment methods: child care centers in the state of Maryland that meet eligibility criteria were filtered for those located within 50 miles of the university and having more than 20 children enrolled. Eligible centers were contacted by the study team to describe the study, assess eligibility, and, if the center is interested, arrange a visit to the center to meet with the director and discuss the intervention and the evaluation. Eligible centers that express interest after this recruitment visit and within the recruitment time frame are invited to participate. Study staff and center liaisons create a recruitment plan for each center that involves print materials, a video on the program, presentations at back‐to‐school nights, and discussion with parents at drop‐offs and pick‐ups Inclusion criteria: cluster: licensed center serving low‐income communities with children aged 3 to 5 years enrolled, childcare staff must be at least 18 years old; participants: child attending participating child care center at least 3 days per week, aged 3 to 5 years, English‐speaking, caregiver anticipates that the child will be enrolled in the center through the spring, and the caregiver gives informed consent; caregiver eligibility criteria include being the child's primary caregiver, living with the child 4 or more days per week, basic English literacy, and being at least 18 years old Exclusion criteria: cluster: Head Start center, childcare staff cannot speak English; participants: child has health problems that would interfere with participation in physical activity or developmental delays that prevent assessment of key study outcomes Age of participating children at baseline: 3 to 5 years Total number randomized by relevant group: 864 children anticipated Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): child care center−based wellness intervention plus a web‐based caregiver intervention Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only intervention, this intervention includes content for caregivers delivered through a caregiver education website. Additional intervention components will span over the course of the child‐only intervention. Each week, new content, including photos of children participating in the child intervention, is loaded to the website Who: providers (TIDieR #5): delivered online with content developed by the CHAMP research team Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, midpoint (approximately 18 weeks), end of intervention (approximately 30 weeks) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): content provided on the website focuses on physical activity, nutrition, and wellness topics relevant to caregivers of preschoolers and co‐ordinated to align with classroom activities. In addition to information and photos of children participating in the child intervention, quizzes and monthly challenges are used to increase engagement. Caregivers are notified when new content is available on the website Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: same as child‐only arm Child‐only arm (control group) Brief name/description (TIDieR #1): child care center−based wellness intervention Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): the goal is to "promote statewide environmental strategies that reduce pediatric obesity and the long‐term health disparities" (quote). The program is based on social cognitive theory and the bioecological model How, where, and when and how much (TIDieR #6 to 8): the intervention involves an 18‐week physical activity program offered through 72 lessons provided 4 days per week for 15 to 20 minutes per day and a 12‐week nutrition program providing 15‐ to 20‐minute twice‐weekly nutrition activities and twice‐weekly opportunities to try new foods. Both programs are delivered in the classroom with the physical activity program implemented during the fall and winter months and the nutrition program offered during the spring months Who: providers (TIDieR #5): child care staff following receipt of 2 trainings, which last 1 to 2 hours each Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, midpoint (approximately 18 weeks), end of intervention (approximately 30 weeks) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): the overall intervention is based on The Food Friends, an evidence‐based preschool program involving a physical activity component focused on promoting gross motor skills (Get Movin' With Mighty Moves) and a healthy eating component (Fun With New Foods). Adaptations were made to the curricula to improve cultural sensitivity and appeal to an urban and semi‐urban mid‐Atlantic population. The curricula have a super‐hero theme and utilize social marketing strategies. Teachers were provided with implementation manuals on lesson plans and activities Tailoring (TIDier #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: "sensitivity analyses are conducted to examine predictors of those caregivers willing to complete the secondary measures" (quote)
Outcomes	The following instruments are being used to measure outcomes relevant to this review Children's dietary intake: a 17‐item, parent‐report, food frequency questionnaire, which has been found to be reliable and moderately valid in children aged 2 to 5 years will be completed at baseline and at the end of the intervention Study authors report that the food frequency questionnaire will be used to assess the following outcomes: fruit intake and vegetable intake, as well as non‐relevant dietary outcomes Children's physical activity levels and sedentary behavior: objective measurement with Actical accelerometers (Philips Resporonics, Minimeter, Bend, Oregon, USA) worn on a band attached to the lateral malleolus of the non‐dominant ankle for 24 hours per day for 7 consecutive days at baseline and at the end of the intervention. Data are collected at 15‐second intervals. Days with incomplete data (fewer than 20 activity counts were 15 seconds and 80 activity counts per minute) will be excluded from analyses Study authors report that accelerometry data will be used to calculate the following outcomes: light physical activity, MVPA, and sedentary activity Children's anthropometry: measured height with a portable stadiometer (Shorr Productions, Olney, Maryland, USA) and weight with a digital scale (TANITA BWB‐800, TANITA, Tokyo, Japan) will be collected at baseline, midline, and end of intervention Study authors report that age‐ and gender‐specific body mass index Z scores will be calculated based on the CDC growth charts Caregivers' dietary intake: the 16‐item, self‐report Food Behavior Checklist questionnaire, which has been correlated with biomarkers for food intake and 24‐hour recall measurements Study authors report that fruit and vegetable intake, as well as non‐relevant dietary outcomes, will be assessed with this questionnaire at baseline and at the end of the intervention Caregivers physical activity levels: the 27‐item self‐report International Physical Activity Questionnaire (IPAQ) Study authors report that the questionnaire will be administered at baseline and at the end of the intervention and provides information on sedentary behavior, as well as job‐related physical activity, transportation physical activity, housework and caring for family, and recreation and leisure‐time physical activity. It is unclear whether time spent in MVPA will also be reported
Starting date	The study began in July 2016, and the trial was registered on April 12, 2017
Contact information	Author's name: Maureen Black Email: mblack@som.umaryland.edu
Notes	Country: USA Setting: childcare centers in Maryland Types of reports: published protocol; trial registration Comments: used the following reports: (1) Armstrong 2019, and (2) trial registration (Clinicaltrials.gov registration number NCT03111264) Conflicts of interest: not known Sponsorship source: National Institute of Diabetes and Kidney Diseases, under award number 1R01DK107761‐01

Trial name or title	Study name: Fuel for Fun
Methods	Study design: cluster‐randomized controlled trial Study grouping: factorial assignment Study aim: this study "builds on prior research to engage multiple sectors of the community to reduce the risk of childhood obesity by promoting healthful food and activity environments, policies and behaviors through: 1) developing and testing the efficacy of a 4th grade comprehensive school‐ and family‐based intervention, 2) applying this intervention to an afterschool setting, and 3) state‐wide program dissemination" (quote) Study period: not known Total number of arms: 4 (note: trial registration indicates 5 arms, including a no intervention control arm) Description of intervention arms: 1. School‐based intervention plus both family intervention and online parent‐based intervention (child + caregiver A); 2. School‐based intervention plus family intervention (child + caregiver B); 3. School‐based intervention plus online parent‐based intervention (child + caregiver C); 4. School‐based condition (child only) Number of clusters per arm: not known Average cluster size: not known Sample size justification and outcome used: power calculations sought to determine minimum sample sizes to detect a clinically relevant change at a power of 80% and a 5% probability of a type 1 error. Study authors based power calculations on data from prior studies with fourth grade Colorado students and their parents. Instead study authors reported sample sizes needed per group for 7 outcomes: child attitude (n = 50), child self‐efficacy (n = 108), child fruit and vegetable preference (n = 127), parent modeling (n = 64), parent self‐efficacy (n = 110), parent fruit and vegetable availability (n = 15), and parent eating competence (n = 105). They did not report the sample sizes needed to detect a change in the primary outcomes (fruit and vegetable consumption at school lunch and student activity level) nor in the secondary outcome (BMI) Unit of allocation: school Missing data handling: not known Reported limitations: 1. The target audience lacks diversity, therefore potentially limiting the generalizability of results; 2. Caregiver involvement will be indirect; 3. If teachers continue teaching fourth grade in participating schools, they will participate in more than 1 intervention arm, which could influence their involvement; 4. Long‐term follow‐up is not possible Randomization ratio and stratification: 1:1:1:1; 8 schools were matched on the percentage of students receiving free or reduced‐priced school meals before randomization Participant compensation or incentives: to motivate participation in the family component, family nights held at schools include a drawing for free cooking and activity prizes. As compensation or participation in accelerometry assessment, children will receive up to USD 25 in gift cards as compensation when they return their device and the device worn by their caregiver. Caregivers will receive e‐gift cards for each dietary recall that they complete and an e‐card and an e‐gift card pin for survey completion
Participants	Baseline characteristics: not known; however, study authors note that the intervention schools will be "low‐to‐moderate income" (quote) Recruitment methods: not known Inclusion criteria: clusters: not known, although all schools were located in 2 districts in the same county in northern Colorado, USA; participants: child enrolled in fourth grade at a participating school and caregiver Exclusion criteria: not known Age of participating children at baseline: fourth grade (estimated to be 8 to 10 years old) Total number randomized by relevant group: total number of children randomized by relevant group has not yet been reported; however, study authors note that they anticipate recruiting 1320 to 1584 children and their parents Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm A (intervention group) Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the family intervention and online intervention for parents Focus of intervention: diet and physical activity Behavior change techniques: all behavior change techniques used in child‐only arm and child + caregiver arms B and C Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): see information reported in child‐only arm and child + caregiver arms B and C Who: providers (TIDieR #5): see providers listed for child‐only arm and child + caregiver arms B and C Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): see materials and procedures listed for child‐only arm and child + caregiver arms B and C Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known Child + caregiver arm B (intervention group) Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the family intervention Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the following techniques were applied separately or differently in this arm: "social support," "shaping knowledge," "repetition and substitution," "reward and threat," "antecedents" Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only intervention, schools assigned to this arm will hold 2 Family Nights per year (fall and spring) at the school, families will receive action packs after each cooking and tasting lesson, and parents will have access to a blog throughout the intervention Who: providers (TIDieR #5): school cafeteria staff will serve a light meal at family nights. Study authors do not report who will deliver other activities specific to this intervention arm. Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): Family Nights include crafts, cooking and tasting stations to mimic what students are learning in the classroom, SPARK games, a light meal, and a drawing for cooking and activity prizes. Action packs encourage parents and other family members to participate with the child in SPARK Active Recess games. Family participation is documented with a parent signature, and the child is asked to return the completed action pack by the following lesson. The parent blog is administered through a private Facebook page and provides tips about cooking with children, encouraging children to try new foods, and physical activities for the family. New content is posted weekly and parents are sent reminders to view the posts Tailoring (TIDieR #9): content of the blog is slightly tailored to each school to align with the dates of intervention activities Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known Child + caregiver arm C (intervention group) Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the online intervention for parents Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the "shaping knowledge" BCT was applied separately or differently in this arm Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): 6 web‐based lessons that can be viewed in any order and as often as desired following completion of the baseline survey. Study authors note that the caregivers can complete the lessons with "individually tailored depth and scope of participation" Who: providers (TIDieR #5): this is a self‐directed program Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): lessons focus on food enjoyment and acceptance, attention to internal regulation, food resource management skills, and physical activity Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention Focus of intervention: diet and physical activity Behavior change techniques: "shaping knowledge," "comparison of behavior," "repetition and substitution," "antecedents" Why: rationale, theory, or goal (TIDieR #2): this intervention builds on prior research and the principles of the Satter eating competence model, social cognitive theory, experiential learning theory, the socioecological model, behavioral economics, and social marketing. Study authors note the importance of addressing the context in which individuals make eating and activity choices, and that for children this includes not only themselves, but their communities, schools, families, and parents How, where, and when and how much (TIDieR #6 to 8): classroom component includes 5 two‐hour cooking lessons and 5 one‐hour tasting lessons taught over the course of 1 academic year (approximately 1 lesson every 3 weeks). Lessons are taught in the classroom or cafeteria. The cafeteria component is delivered during the weeks that cooking and tasting lessons are delivered. The SPARK active recess activities are led at least 4 days per week during the regular 20‐minute daily recess period Who: providers (TIDieR #5): the classroom component is taught by graduate nutrition students trained as food educators, with assistance from another nutrition student and the classroom teacher. Cafeteria staff deliver the cafeteria component. Trained active recess leaders (university health and exercise science students) lead the active recess component Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): cooking and tasting lessons ("Cooking with Kids—Colorado") use experiential learning techniques and emphasize practical cooking skills using fresh and affordable foods. FFF Cafeteria Connections includes serving fruit and vegetable items that children have prepared in the classroom on the lunch menu, increasing fruit and vegetable visibility, and providing verbal encouragement to select fruits and vegetables. The SPARK Active REcess Activities include active games and the provision of additional equipment that supports active recess Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known
Outcomes	The following instruments are being used to measure outcomes relevant to this review at baseline, 7 months (end of intervention), and 1 year (follow‐up) Children's dietary intake: three 24‐hour recalls conducted with the caregiver over the phone Study authors do not report the specific diet outcomes that will be calculated Children's physical activity levels: objective measurement with 7‐day accelerometry (75 Hz, GENEActiv) and child‐reported measurement using an adapted version of the Godin/Shephard questionnaire Study authors report that accelerometry data will be used to calculate MVPA for weekend day, weekday, and specific time periods. The questionnaire instrument also will be used to calculate total MVPA Children's sedentary behavior: children will be asked how many hours per day they spend watching television, playing video games, or using a computer (not for homework) Sedentary behavior will be reported in hours per day Children's anthropometry: height measured with portable stadiometer (SECA 213) and weight measured with standard scale (Health‐o‐meter 394KLX) Study authors report that body mass index Z scores will be calculated at the end‐of‐intervention assessment and at 1‐year follow‐up assessment Caregivers' dietary intake: 24‐hour recalls conducted with the National Cancer Institute's Automated Self‐administered 24‐hour (ASA24) recall system Study authors do not report the specific diet outcomes that will be calculated Caregivers' physical activity levels: objective measurement with 7‐day accelerometry (75 Hz, GENEActiv) and parent‐reported measurement using the International Physical Activity Questionnaire (IPAQ) Study authors report that accelerometry data will be used to calculate weekend MVPA, weekday MVPA, and MVPA for specific time periods
Starting date	The study began in July 2012, and the trial was registered on July 7, 2015
Contact information	Author's name: Leslie Cunningham‐Sabo Email: leslie.cunningham‐sabo@colostate.edu
Notes	Country: USA Setting: schools in northern Colorado Types of reports: published protocol; trial registration Comments: used the following reports: (1) Cunningham‐Sabo 2016, and (2) trial registration (Clinicaltrials.gov registration number NCT02491294) Conflicts of interest: "the authors declare that they have no competing interests" (quote) Sponsorship source: National Institute of Food and Agriculture, US Department of Agriculture, under award number 2012‐68001‐19603

Trial name or title	Study name: MINI SALTEN
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "the main aim of MINI SALTEN is to assess the effects of a technology family‐based and PA school‐based intervention on (1) physical activity, and (2) quality of diet and eating behaviour in first grade children of the city of Buenos Aires. The specific aims are to (a) evaluate the effects of the intervention on children’s specific eating habits (fruit and vegetable consumption, energy intake, snack and breakfast quality), (b) evaluate progression of body mass index (BMI) over time, and (c) identify parental factors associated with changes in PA and in children’s quality of diet" (quote) Study period: July 2015 to November 2016 Total number of arm: 4 Description of intervention arms: 1. Active breaks intervention and virtual intervention (child + caregiver); 2. Active breaks intervention only (child only); 3. Virtual intervention only (not eligible); 4. No intervention control (not eligible) Number of clusters per arm: 3 Average cluster size: 35 Sample size justification and outcome used: "assuming approximately 50% participation rate, the aim is to enrol a minimum of 200 dyads, i.e. 50 per trial arm. Assuming an additional 20% attrition, it is expected to collect data on 160 dyads (40 per arm, an average of 13 per school)... the target sample size of N = 160 participants (40 in each of the four conditions) yields a 80% power to detect an effect size of 0.22... An effect size of 0.22 corresponds to a change of 5 min/day in moderate/vigorous PA (within‐cell SD = 11) and a change of 5.4 min/day of sedentary time (within‐cell SD = 12)..." Unit of allocation: school Missing data handling: not known Reported limitations: not known Randomization ratio and stratification: 1:1:1:1 Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: not known Inclusion criteria: cluster: not known, although the Ministry of Education of the city of Buenos Aires, Argentina, pre‐selected a pool of eligible schools; participants: first grade student at participating school Exclusion criteria: cluster: not known; participants: children with severe intellectual difficulties, limitations to engage in physical activity, suffering from illnesses compromising nutrition or food selection, or taking medication known to affect body weight, or parents who do not have access to Internet or who have severe intellectual disabilities Age of participating children at baseline: first grade (estimated age: 6 years) Total number randomized by relevant group: 200 children anticipated Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): active breaks intervention for children at school plus virtual intervention for families Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): parental involvement can support the success of school‐based interventions. There is a strong potential for communication via smartphones and tablets to improve health interventions, but evidence of their effectiveness remains scarce. The web‐based intervention aimed to encourage the whole family to eat healthy, increase mothers' knowledge of the benefits of physical activity and consequences of sedentary behavior, and propose fun physical activities for children. The use of theory in this intervention arm is not specified How, where, and when and how much (TIDieR #6 to 8): a web‐based program comprising 23 presentations was available during the length of the program. Presentations could be viewed on a smartphone, tablet, or computer by families during their free time. Study authors noted that presentations would be viewed "ideally at home" (quote) Who: providers (TIDieR #5): not known; delivered online Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 1 year (end of intervention) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): the web‐based intervention targeted mothers but was accessible to other family members. The intervention covered the following thematic areas: breakfast, physical activity, water intake, fruit and vegetable consumption, energy balance, parents as role models, what we eat, and snacking. Each thematic area was addressed in 2 to 5 sequential presentations Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): active breaks intervention for children at school Focus of intervention: diet and physical activity Behavior change techniques: "shaping knowledge," "comparison of behavior," "repetition and substitution," "comparison of outcomes" Why: rationale, theory, or goal (TIDieR #2): studies from other countries, especially high‐income countries, have demonstrated the effectiveness of obesity prevention interventions. There is lack of evidence regarding the effectiveness of healthy eating and physical activity interventions with children and their parents in Argentina. The intervention is framed within the Analysis Grid for Elements Linked to Obesity (ANGELO) ecological model, which emphasizes environmental modifications How, where, and when and how much (TIDieR #6 to 8): physical activity instructors provided guided activities 3 times per week during 2 school breaks for 2 school semesters (second semester of first grade and first semester of second grade) and suggested activities that could be implemented in physical education class. This intervention was complemented with a partial version of the web‐based program provided to the child + caregiver arm, but the target audience for this web‐based material and its scope are not clear Who: providers (TIDieR #5): 6 physical activity instructors, who rotated among participating schools to reduce bias that could have been introduced by an individual facilitator Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 1 year (end of intervention) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): physical activity instructors were provided a list of 15 suggested playful, non‐competitive games and activities designed to emphasize motivation, having fun, and sharing. These games and activities were designed to promote MVPA for children aged 5 to 7 years, with the goal that children spend 75% of their time running or jumping. Physical activity instructors guided these activities during school breaks, and teachers were encouraged to implement these during physical education classes. The study also provides schools with specific gear to support children's physical activity and includes a web‐based program with content related to associated benefits and strategies to promote physical activity Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known
Outcomes	The following instruments are being used to measure outcomes relevant to this review at baseline and at 1 year (end of intervention) Children's dietary intake: one 24‐hour recall administered at school by a nutritionist to the caregiver Study authors report that the following outcomes will be assessed at each time point: total energy intake, percentage energy from saturated fat intake, fruit and vegetable intake, and water intake, as well as non‐relevant outcomes Children's physical activity levels and sedentary behavior: objective measurement with tri‐axial accelerometer (GT3X+ Actigraph, Pensacola, Florida, USA) worn on an elasticized belt at the waist on the right mid‐axillary line for 24 hours per day for 7 consecutive days and removed only for water activities. Study authors report that the minimal acceptable duration of accelerometer data is 5 days, including at least 1 weekend day, with at least 10 hours of wear time per day Study authors report that accelerometry data will be used to calculate the following outcomes at each time point: steps, light physical activity, MVPA, sedentary time, as well as non‐relevant outcomes Children's anthropometry: height measured with portable stadiometer (SECA 206, Hamburg, Germany) and weight measured with a portable digital scale (SECA AURA 807) Study authors report that body mass index Z scores using WHO reference growth charts will be calculated at each assessment Caregivers' dietary intake: one 24‐hour recall administered at school by a nutritionist Study authors report that the following outcomes will be assessed at each time point: total energy intake, percentage energy from saturated fat intake, fruit and vegetable intake, and water intake Caregivers' physical activity levels: caregiver‐reported measurement using the Global Physical Activity Questionnaire (GPAQ; WHO) Study authors report that the questionnaire provides information on sedentary behavior and physical activity at work, during leisure time, and for transport
Starting date	The study began in July 2015, and the trial was registered on March 14, 2016
Contact information	Author's name: Irina Kovalskys Email: ikovalskys@ilsi.org.ar
Notes	Country: Argentina Setting: schools in Buenos Aires, Argentina Types of reports: published protocol; abstract; trial registration Comments: used the following reports: (1) Kovalskys 2017c, (2) Kovalskys 2017b, and (2) trial registration (ISRCTN58093412) Conflicts of interest: "the authors declare that they have no competing interests" (quote) Sponsorship source: Coca Cola Foundation

Trial name or title	Study name: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "this study will implement and evaluate an after‐school program with exercise, education, and diet components designed to improve bone quality and muscle strength in early elementary school children” (quote) Study period: study start date: June 1999, study completion date: May 2004 Total number of arms: 3 Description of intervention arms: 1. The BONES Project plus a parent/caregiver component (child + caregiver); 2. The BONES Project (child only); 3. No intervention control (not eligible) Number of clusters per arm: not known Average cluster size: not known Sample size justification and outcome used: not known Unit of allocation: after‐school program Missing data handling: not known Reported limitations: not reported Randomization ratio and stratification: not known Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: not known Inclusion criteria: clusters: after‐school programs in Massachusetts and Rhode Island, USA; participants: child aged 6 to 9 years, enrolled in a participating after‐school program, and living in Massachusetts or Rhode Island, USA Exclusion criteria: clusters: not known; participants: not known Age of participating children at baseline: 6 to 9 years Total number randomized by relevant group: 1500 children anticipated Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): BONES Project plus a parent/caregiver component Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): caregivers will receive a newsletter and worksheet 5 times per year Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: not known, although it appears that a baseline assessment and 2 subsequent assessments will take place Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): not known Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): BONES Project Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): osteoporosis is a serious public health concern. Risk of osteoporosis can be reduced by building an adequate bone reserve by optimizing bone development during childhood How, where, and when and how much (TIDieR #6 to 8): each year for 2 years, the curriculum will be implemented 4 days per week over a 20 to 25‐week period Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: not known, although it appears that a baseline assessment and 2 subsequent assessments will take place Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): not known Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known
Outcomes	The following relevant outcomes relevant to this review were measured at assessments (time points not specified) Children's physical activity levels (instrument not specified) Children's anthropometry: measured height and weight (instruments not specified)
Starting date	The study began in June 1999, and the trial was registered on July 22, 2003
Contact information	Author's name: Christina Economos Email: christina.economos@tufts.edu Country: USA Setting: after‐school programs in Massachusetts and Rhode Island Types of reports: trial registration Comments: used the following report: (1) trial registration (Clinicaltrials.gov registration number NCT00065247) Conflicts of interest: not known Sponsorship source: National Institute of Child Health and Human Development (R01HD037752)
Notes

Trial name or title	Study name: Texts for Healthy Teens (T4HT): A Health Education Program for Adolescents
Methods	Study design: randomized controlled trial Study grouping: factorial assignment Study aim: “the overall objective is to examine if participating in an SMS‐transmitted health educational program targeting a cluster of dietary factors over a period of weeks during the years of adolescence can induce durable changes toward more healthful dietary habits” (quote) Study period: study start date: June 2016, estimated study completion date: December 2017 Total number of arms: 9 Description of intervention arms: 1. Tailored SMS program implicating friend and mother (child + caregiver A); 2. Standardized SMS program implicating friend and mother (child + caregiver B); 3. Tailored SMS program implicating friend, not mother (child only A); 4. Standardized SMS program implicating friend, not mother (child only B); 5. Tailored SMS program implicating mother, not friend (child + caregiver arm C); 6. Standardized SMS program implicating mother, not friend (child + caregiver D); 7. Tailored SMS program not implicating mother or friend (child only C); 8. Standardized SMS program not implicating mother or friend (child only D); 9. No SMS program (not eligible) Number of clusters per arm: not relevant Average cluster size: not relevant Sample size justification and outcome used: not known Unit of allocation: child Missing data handling: not known Reported limitations: not known Randomization ratio and stratification: not known Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: not known Inclusion criteria: participants: participating in the National Danish Birth Cohort and aged 14 to 15 years Exclusion criteria: participants: lacking information from maternal interviews 1 and 2 Age of participating children at baseline: 14 to 15 years Total number randomized by relevant group: 8000 children anticipated Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Child + caregiver arm A (intervention group) Brief name/description (TIDieR #1): tailored SMS program implicating friend and mother Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): about 40 SMS messages will be distributed over 4 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): all SMS messages focus on SSB intake, fruit and vegetable intake, or fish intake. A friend and the mother of the participant are invited to participate Tailoring (TIDieR #9): SMS messages focus on a specific dietary factor identified through responses to an online dietary questionnaire Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only A (control group) Brief name/description (TIDieR #1): tailored SMS program implicating friend, not mother Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): about 40 SMS messages will be distributed over 4 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): all SMS messages focus on SSB intake, fruit and vegetable intake, or fish intake. A friend of the participant is invited to participate Tailoring (TIDieR #9): SMS messages focus on a specific dietary factor identified through responses to an online dietary questionnaire Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child + caregiver arm B (intervention group) Brief name/description (TIDieR #1): standardized SMS program implicating friend and mother Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): 121 messages will be distributed over 12 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): SMS messages align with the standard program targeting a cluster of dietary factors. A friend and the mother of the participant are invited to participate Tailoring (TIDieR #9): no tailoring Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only B (control group) Brief name/description (TIDieR #1): standardized SMS program implicating friend, not mother Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): 121 messages will be distributed over 12 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): SMS messages align with the standard program targeting a cluster of dietary factors. A friend of the participant is invited to participate Tailoring (TIDieR #9): not tailored Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child + caregiver arm C (intervention group) Brief name/description (TIDieR #1): tailored SMS program implicating mother, not friend Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): about 40 SMS messages will be distributed over 4 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): all SMS messages focus on SSB intake, fruit and vegetable intake, or fish intake. The mother of the participant is invited to participate Tailoring (TIDieR #9): SMS messages focuses on a specific dietary factor identified through responses to an online dietary questionnaire Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only C (control group) Brief name/description (TIDieR #1): tailored SMS program not implicating mother or friend Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): about 40 SMS messages will be distributed over 4 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): all SMS messages focus on SSB intake, fruit and vegetable intake, or fish intake Tailoring (TIDieR #9): SMS messages focus on a specific dietary factor identified through responses to an online dietary questionnaire Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child + caregiver arm D (intervention group) Brief name/description (TIDieR #1): standardized SMS program implicating mother, not friend Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): 121 messages will be distributed over 12 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): SMS messages align with the standard program targeting a cluster of dietary factors. The mother of the participant is invited to participate Tailoring (TIDieR #9): not tailored Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only arm D (control group) Brief name/description (TIDieR #1): standardized SMS program not implicating mother or friend Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): 121 messages will be distributed over 12 weeks Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 6 months, 12 months Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): SMS messages align with the standard program targeting a cluster of dietary factors Tailoring (TIDieR #9): not tailored Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known
Outcomes	The following relevant outcomes relevant to this review are being measured at baseline, 6 months, and 12 months Children’s dietary intake and quality: online questionnaires (instrument not specified) Study authors report that the online questionnaire will be used to measure change from baseline for sugar‐sweetened beverage intake, fruit and vegetable intake, fish intake, and a measure of overall dietary quality
Starting date	The study began in June 2016, and the trial was registered on June 22, 2016
Contact information	Author's name: Sjurdur Olsen Email: sfo@ssi.dk Country: Denmark Setting: any location in Denmark Types of reports: trial registration Comments: used the following report: (1) trial registration (Clinicaltrials.gov registration number NCT02809196) Conflicts of interest: not known Sponsorship source: not known
Notes

Trial name or title	Study name: Kids' Obesity Prevention Program (KOP) Part 2
Methods	Study design: randomized controlled trial Study grouping: parallel group Study aim: this study aims “to evaluate a motion‐controlled serious game regarding its acceptance and efficacy in a randomized controlled trial in parents of primary school children aged 9 to 12 years” (quote) Study period: October 2016 to April 2017 (estimated) Total number of arms: 2 Description of intervention arms: 1. Serious game playing + parental involvement (child + caregiver); 2. Serious game playing only (child only) Number of clusters per arm: not relevant Average cluster size: not relevant Sample size justification and outcome used: not known Unit of allocation: child Missing data handling: not known Reported limitations: not known Randomization ratio and stratification: 1:1 Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: fourth grade students from a single school who received the original KOP intervention will be randomly allocated to an intervention group and a control group Inclusion criteria: participants: all fourth grade children from a single primary school Exclusion criteria: participants: children with massive linguistic difficulties (after study participation) Age of participating children at baseline: 9 to 12 years Total number randomized by relevant group: total number of children randomized by relevant group has not yet been reported; however, study authors note that they anticipate enrolling 34 participants Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): motion‐controlled serious game with parental involvement Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the following technique was applied separately or differently in this arm: "social support" Why: rationale, theory, or goal (TIDieR #2): in addition to the child‐only arm, the involvement of parents in interventions appears to be very important to reach a sustained effect How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only arm, children play the game at home with their parents between sessions 1 and 2 Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 2 weeks, 4 weeks (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): same as child‐only arm Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): motion‐controlled serious game focusing on nutrition, PA, and psychosocial factors in primary schools Focus of intervention: diet and physical activity Behavior change techniques: "shaping knowledge" Why: rationale, theory, or goal (TIDieR #2): video games, including exergames, serious games, or combined approaches offer additional chances in treatment and prevention of obesity by approaching children in their environment and motivating them to deal with lifestyle topics How, where, and when and how much (TIDieR #6 to 8): children participate in 2 game‐playing sessions over 2 weeks (35 minutes per session) Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 2 weeks, 4 weeks (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): the motion‐controlled game addresses 3 core areas: nutrition, PA, and psychosocial factors. The nutrition component includes information on the food pyramid and the energy density of foods and beverages, as well as a self‐reflexive diagnostic tool to analyze daily food intake. Stress and coping strategies are also addressed by relaxation exercises and a reflection exercise about leisure behavior Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known
Outcomes	The following instruments are being used to measure outcomes relevant to this review at baseline, 2 weeks, 4 weeks (follow‐up) Children's dietary intake: food frequency questionnaire (FFQ) completed by children Study authors report that the FFQ will be used to assess consumption of specific foods Children’s physical activity: Self‐reported validated questionnaire completed by children Study authors do not report specific physical activity outcomes that will be calculated Caregiver's dietary intake: food frequency questionnaire (FFQ) completed by parents Study authors report that the FFQ will be used to assess consumption of specific foods Caregiver’s physical activity: self‐reported validated questionnaire completed by parents Study authors do not report specific physical activity outcomes that will be calculated
Starting date	The study began in January 2016, and the trial was registered on October 24, 2016
Contact information	Author's name: Isabelle Mack Email: isabelle.mack@medizin.uni‐tuebingen.de
Notes	Country: Germany Setting: primary school in Germany Types of reports: trial registration Comments: used the following report: (1) trial registration (Clinicaltrials.gov registration number NCT02942823) Conflicts of interest: not known Sponsorship source: not known

Trial name or title	Study name: ¡Míranos! Look at Us, We Are Healthy!
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: this study “will use a cluster randomized controlled design to test the efficacy of the ¡Míranos! intervention in preventing excessive weight gain and promoting the development of healthy habits in young children enrolled in Head Start" (quote) Study period: May 2018 to August 2021 (estimated) Total number of arms: 3 Description of intervention arms: 1. Combined center‐ and home‐based intervention (child + caregiver); 2. Center‐based intervention (child only); 3. Attention control arm offering Head Start−endorsed obesity prevention curriculum (not eligible) Number of clusters per arm: 4 Average cluster size: 37 (estimated) Sample size justification and outcome used: study authors based power calculations on data from a previous study with a similar center‐based intervention and home‐based intervention components. For the present study, study authors reported that “a sample size of 12 centers (i.e., 4 centers/group) with 29 children per center” (quote) was needed to detect a difference between the child + caregiver and child‐only arms and the attention control arm of 0.53 BMI units at a power of 80% and a 5% probability of a type 1 error, assuming an ICC of 0.003 and SD = 1.147. “The final sample size was increased to 37 (> 29/0.8) children per center (i.e. 37 × 12 = 444 children in total) to account for an attrition rate of 80%” (quote). Unit of allocation: Head Start center Missing data handling: study authors reported that participants with missing data will be compared with participants with complete data to assess any differences in demographic and outcome measures, using available data. If data are missing at random (MAR), standard computational algorithms will be used to generate appropriate parameter estimates using all available data. If the MAR assumption is in doubt, missing data will be imputed using the multiple imputations with chained equations approach. Specifically, missing values will be imputed by adjusting for time of measurement and demographics to create 10 imputed data sets. Effect sizes then will be combined using the Rubin’s rules Reported limitations: 1. Head Start staff will not be blinded to treatment assignment; 2. Data collection staff will not be blinded to treatment assignment Randomization ratio and stratification: 1:1:1; stratified by the organization overseeing each center and center enrollment size Participant compensation or incentives: to increase parental participation and compliance, incentives (up to USD 30) will be provided for completing daily logs (USD 3 per day) and parent surveys (USD 9 and raffles for a tricycle); staff members will receive cash incentives for their centers by participating in center‐wide wellness challenges
Participants	Baseline characteristics: not known Recruitment methods: Head Start centers were selected from 2 organizations that joined the study as collaborators. Twelve centers were determined to meet the eligibility criteria and have been randomly assigned to 1 of the 3 treatment conditions (3 centers from organization A and 9 centers from organization B). Recruitment packets will be sent home with eligible children from each participating center. Children will receive a coloring book if their parents return a signed consent form agreeing or declining to participate in the study Inclusion criteria: clusters: full‐day center (more than 7 hours of care per day), at least 1 classroom enrolling children aged 3, agreement to modify center physical activity and nutrition policies, agreement not to participate in other health‐related studies; participants: child enrolled in a participating center, aged 3 years at baseline, parental consent, 1 child per family Exclusion criteria: not known Age of participating children at baseline: 3 years Total number randomized by relevant group: total number of children randomized by relevant group has not yet been reported; however, study authors note that they anticipate recruiting 444 children and their parents Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): center‐based intervention plus a home‐based intervention designed to engage parents Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the following technique was applied separately or differently in the child + caregiver arm: "goals and planning," "social support," "shaping knowledge," "comparison of behavior," "repetition and substitution," "reward and threat" Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only arm, parents will receive 8 monthly peer‐led education sessions during child pick‐up time (15 to 20 minutes per session). Parents will be asked to complete a “Family Health Challenge” in the week following each educational session (n = 8). They will receive 16 biweekly health newsletters and 3 home visits Who: providers (TIDieR #5): trained Head Start parents will deliver the educational sessions; home visits will be conducted by trained family service workers Economic variables and resources required for replication: not known; cost‐effectiveness analysis is planned to estimate program delivery costs Strategies to address disadvantage: focus on low‐income, predominantly Latino preschool children Subgroups: not known Assessment time points: baseline, 8 months (end of intervention), 21 months (1‐year post‐intervention follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): tailoring (TIDieR #9): in addition to the child‐only arm, peer‐led education sessions will focus on evidence‐based strategies related to positive child feeding, increasing PA and sleep duration, reducing screen time at home, limiting sugary drinks, and promoting water. Parents will receive take‐home bags after each educational session containing a health‐themed storybook, a bilingual family activities newsletter, an interactive game, and a “Family Health Challenge” form. Newsletters will provide tips on modifying family health behaviors, healthy snack and meal recipes, and information on community resources to promote healthier lifestyles. Family health challenges will focus on a targeted health behavior (e.g. drinking water); parents will be able to choose 1 of 3 challenges to complete over 7 days Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): center‐based intervention designed to enhance PA opportunities, reduce sedentary time, and promote healthy eating Focus of intervention: diet and physical activity Behavior change techniques: "goals and planning," "shaping knowledge," "comparison of behavior," "repetition and substitution" Why: rationale, theory, or goal (TIDieR #2): the intervention program was based on theories of early child development, social cognitive theory, and socioecological models and was informed by a systems approach. Intervention components were culturally tailored for Latino preschoolers and their parents. The program was designed to develop long‐term health habits by targeting energy‐balance related behaviors among low‐income predominantly Latino preschool children, who are at higher risk for obesity than non‐Latino children How, where, and when and how much (TIDieR #6 to 8): physical activity and nutrition policies will be implemented across all intervention centers during the 7‐month intervention period. Children will participate in daily PA (30 minutes of structured and 60 minutes of non‐structured play) during outdoor/indoor play sessions, learning center time, and transitions. Children will also participate in health education activities at least twice weekly Who: providers (TIDieR #5): center‐based intervention activities will be delivered by trained Head Start teachers Economic variables and resources required for replication: not known; cost‐effectiveness analysis is planned to estimate program delivery costs Strategies to address disadvantage: focus on low‐income, predominantly Latino preschool children Subgroups: not known Assessment time points: baseline, 8 months (end of intervention), 21 months (1‐year post‐intervention follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): physical activity policies will focus on offering 90 minutes of teacher‐led physical activity to children every day. Nutrition polices will focus on offering balanced healthy meals and snacks utilizing the USDA Child and Adult Care Food Program best practice recommendations. Teachers will meet children’s daily PA goals using Activity Cards, active learning activities that combine literacy and numeracy skills with physical activities, and music CDs and dance videos. Health education activities will be based on the Healthy Habits for Life (HHL) resource kit. The HHL uses Sesame Street characters to promote PA and healthy eating and consists of 9 modules with short learning activities, hands‐on games, and interactive DVD activities Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known
Outcomes	The following instruments are being used to measure outcomes relevant to this review at baseline, 8 months (end of intervention), and 21 months (1‐year post‐intervention follow‐up) Children's dietary intake: NHANES dietary screener completed by parents; aggregated plate waste tests Study authors report that dietary screener data will be used to assess fruit intake, vegetable intake, and beverage intake; intake at childcare centers will also be assessed through aggregated plate waste Children's physical activity levels and sedentary behavior: objective measurement with 7 days of accelerometry (specific instrument not reported) and parent‐report measurement of screen time using a 7‐day log Study authors report that accelerometry data will be used to calculate minutes of light, moderate, and vigorous physical activity, and sedentary activity, and the parent‐report log will be used to track the time that the child spends watching TV/DVD Children’s anthropometry: height and weight measured twice at the beginning of the school day with no shoes and light clothes, using a stadiometer and a digital weight scale (specific instruments not reported) Study authors report that BMI, BMI percentile, and zBMI for age and gender will be calculated using the average of the 2 measures‐based CDC growth charts Caregivers' dietary intake: self‐reported; measurement tool not reported Study authors do not report the specific diet outcomes that will be calculated Caregivers’ physical activity levels: self‐reported; measurement tool not reported Study authors do not report specific physical activity outcomes that will be calculated
Starting date	The study began in May 2018, and the trial was registered on July 18, 2018
Contact information	Author's name: Zenong Yin Email: zenong.yin@utsa.edu
Notes	Country: USA Setting: Head Start centers in San Antonio, Texas Types of reports: published protocol; trial registration Comments: used the following reports: (1) Yin 2019, and (2) trial registration (Clinicaltrials.gov registration number NCT03590834) Conflicts of interest: "the authors declare that they have no competing interests" (quote) Sponsorship source: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, under award number R01DK109323

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Caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors

Emily H Morgan

Anel Schoonees

Urshila Sriram

Marlyn Faure

Rebecca A Seguin‐Fowler

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

1. Methods planned in the protocol but not used in this review.

Types of participants

Types of interventions

Intervention group

Control group

Comparisons

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Dichotomous data

Continuous data

Unit of analysis issues

Multiple treatment groups

Cluster‐randomized trials

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

"Summary of findings" table

Results

Description of studies

Results of the search

1.

Included studies

Study design

Setting

Participants

Interventions

Comparison 1

Comparison 2

Comparison 3

Outcomes

Primary outcomes

Secondary outcomes

Excluded studies

Ongoing studies

Studies awaiting classification

Risk of bias in included studies

2.

3.

Random sequence generation

Allocation

Blinding

Blinding of participants and personnel