Abstract
Introduction
Primary prevention is a public health strategy that hitherto has not been widely applied in obesity prevention research. The objectives were to examine the long-term effects of the Healthy Start primary obesity prevention study, an intervention conducted among healthy weight children susceptible to develop obesity.
Methods
At baseline, children (2–6 years) were allocated to the intervention group (n = 271), the control group (n = 272), or the shadow control group (n = 383). Children in the shadow control group had no contact with project staff during the intervention period (1.3 years on average). The intervention was designed to deliver individually tailored improvements in diet and physical activity habits, optimization of sleep quantity and quality and reduce family stress. After the intervention was completed, height and weight at school entry were obtained from the Danish National Child Health Register when children were around 7 years. The average follow-up time was 2.7 years after baseline. Linear regression analyses on annual changes in BMI (ΔBMI) and BMI z-scores (ΔBMIz) were conducted.
Results
At mean 2.7 years after the baseline examination, no differences were observed between the intervention and control group in ΔBMI (β = 0.07 [−0.02; 0.15], p = 0.14) or ΔBMIz (β = 0.04 [−0.02; 0.10], p = 0.19). Likewise, no differences were observed between the intervention and shadow control group in ΔBMI (β = −0.03 [−0.12; 0.06], p = 0.50) or in ΔBMIz (β = −0.02 [−0.08; 0.05], p = 0.62).
Conclusion
We are still in urgent need of more primary overweight prevention interventions to begin to understand how to prevent that healthy weight children develop overweight.
Keywords: Prevention, Intervention, Childhood, Obesity
Introduction
Childhood obesity remains a major public health challenge [1], not least because of its psychological and physiological consequences [2, 3]. Development of obesity early in life also increases the risk of obesity in adulthood (adding risks of other comorbidities and early mortality [4–6]), particularly in children with severe obesity [3]. Overweight and obesity have multiple causes related to lifestyle behavior, i.e., energy balance, sleep, and psychological factors [7]. However, children born with a high birth weight, with overweight 1st degree relatives, or from socially disadvantaged families are more susceptible to develop obesity than others [8].
Effective intervention tools for primary prevention, denoting prevention of overweight development among children with healthy weight, are essential to overcome the high prevalence of children with overweight or obesity [9]. However, published interventions until now have included samples mixed of study participants with both healthy weight and overweight or obesity [1, 10] which does not allow distinguishment between primary prevention and treatment effects [11]. In addition, only about 20–25% of the previous randomized controlled trials (RCTs) were effective, and few have performed a long-term follow-up (≥12 months post-intervention), despite the fact that long-term follow-up studies are important to determine the sustained effects of conducted interventions [1, 9, 12]. Since the prevalence of overweight and obesity increases with age, intervention impacts may appear small immediately after intervention endpoint but may be magnified in the longer term [13].
The Healthy Start was a primary prevention intervention aimed at preventing high gains in fat and weight in healthy weight preschool children, who were all susceptible to future obesity. Analyses immediately after the intervention was completed showed beneficial but clinically small effects on body composition [11] while effects for BMI were not significant. The aim of this study was to explore the long-term effects (2.7 years after baseline) of the Healthy Start intervention study.
Materials and Methods
Based on information from the Danish Medical Birth Registry, all children born in 11 municipalities in the greater Copenhagen area between January 1st, 2004, and December 31st, 2007, with either a high birth weight (>4,000 g), or a mother with overweight prior to pregnancy (BMI >28 kg/m2) were selected [14]. Children with maternal low educational level (≤10 years) were selected from the administrative birth forms (n = 378) in one municipality. A total of 3,722 children were allocated (using computer-based randomization) into three groups: the intervention group (n = 1,523), the control group (n = 1,535), and the shadow control group (n = 664). Children allocated to the intervention and control groups were sent a written invitation to participate in the study. A total of 21% in the intervention group (n = 320) and 21% in the control group (n = 315) accepted the invitation and had a baseline examination.
Children in the shadow control group were not examined by project staff, but information on height and weight development in this group was retrieved from their family general practitioners. Sampling and allocation procedures have been described in detail elsewhere [14]. At the baseline examination, children in the intervention group (n = 320) and the control group (n = 315) had height and weight measured by project staff. Children that according to the International Obesity Task Force (IOTF) criteria [15] were found to have overweight (including obesity), according to age and sex were excluded. A total of n = 271 healthy weight children were subsequently included in the intervention group, and n = 272 children with healthy weight were included in the control group at baseline. A total of n = 383 children with healthy weight were included in the shadow control group at baseline. The specific measurement procedures have been published previously.
All children were aged 2–6 years at baseline. The Healthy Start study is registered at ClinicalTrials.gov (ID NCT01583335).
The intervention was designed to deliver individually tailored improvements in diet and physical activity habits, optimization of sleep quantity and quality and reduce family stress. All children in the intervention group were offered up to 10 meetings with a health consultant and were also offered to participate in bi-monthly cooking classes focused on healthy cooking and monthly play arrangements focusing on active play and social interaction.
The average intervention period was 1.3 years. The intervention procedures have been described in detail elsewhere [11, 14].
Height and weight at school entry was obtained from the Danish National Child Health Register when the children were around 7 years. This information was obtained by linkage with each child’s individual Central Person Registration number. Information on height and weight at school entry was obtained from n = 241 children (89%) in the intervention group, n = 236 children (87%) in the control group, and n = 339 (88%) in the shadow control group. Information on height and weight was used to calculate BMI at school entry. The International Obesity Task Force (IOTF) criteria for overweight (including obesity), according to age and gender were applied [15]. The average follow-up time in this study was 2.7 years (after baseline).
Statistical Methods
BMI z-scores (BMIz) were generated using a power transformation in increments of 0.1 years, applying national reference z-score to the study population [16]. Linear regression analyses were performed to test the effect of the intervention on annual changes in BMI (ΔBMI) and BMI z-scores (ΔBMIz) between baseline and school entry. Logistic regression was performed, to test the effect of the intervention on the prevalence of overweight or obesity at school entry.
Analyses were adjusted for sex (information obtained from the Danish Medical Birth Register), baseline age, and baseline measure of outcome. We used clustered standard errors to take sibship clustering into account. All statistical tests were two-tailed, with a significance level at 0.05. Analyses were performed using Stata SE 14 (StataCorp LP, College Station, TX).
Analyses were restricted to children with information on height and weight at school entry. Analyses were conducted in two steps.
-
1.
Step 1 included all children who were included in the Healthy Start study at baseline.
-
2.
Step 2 included children who completed the Healthy Start study (defined as children who completed the 1.3 years intervention study period and had a follow-up examination).
Ethics
The Scientific Ethical Committee of the Capital Region in Denmark decided that the project was not a bioethics project, and consequently did not need approval from the Danish Bioethics Committee (journal number H-A-2007-0019). The Danish Data Protection Agency approved the study (journal number: 2015-41-3937). Written informed consent to use the collected data for research purpose was obtained from all parents in the intervention and the control groups. It was not necessary to obtain written informed consent from parents in the shadow control group in where information on height and weight was provided by medical records.
Results
Descriptive participant characteristics (restricted to children with information on height and weight at school entry) are shown in Table 1.
Table 1.
Participant baseline characteristicsa
| Intervention group | Control group | Shadow control group | |
|---|---|---|---|
| All | n = 241 | n = 236 | n = 339 |
| Girls, % | 45.2 | 40.3 | 38.1 |
| Age, years | 4.0 (1.1) | 4.0 (1.1) | 3.9 (1.1) |
| BMI, kg/m2 | 15.9 (1.0) | 16.0 (1.0) | 15.9 (1.0) |
| BMIz, SD | 0.0 (0.8) | 0.1 (0.7) | −0.0 (0.9) |
| Overweight/obesity at school entry, n (%) | 22 (9) | 18 (8) | 29 (9) |
| Completers | n = 141 | n = 172 | |
| Girls, % | 44.7 | 43.6 | |
| Age, years | 4.0 (1.1) | 4.0 (1.1) | |
| BMI, kg/m2 | 15.9 (1.0) | 16.0 (1.0) | |
| BMIz, SD | 0.1 (0.8) | 0.1 (0.7) | |
| Overweight/obesity at school entry, n (%) | 11 (8) | 15 (9) |
aRestricted to children with information on height and weight at school entry.
Intervention versus Control Group
Among all children included in the Healthy Start intervention at baseline, no differences were observed between the intervention and the control group in ΔBMI (β = 0.07 [−0.02; 0.15], p = 0.14) or ΔBMIz (β = 0.04 [−0.02; 0.10], p = 0.19) (Table 2) at 2.7 years after the baseline examination. Furthermore, no difference in the risk of developing overweight were observed between the intervention group and the control group (OR 1.45 [95% CI 0.73; 2.87] p = 0.28).
Table 2.
Mean differences in annual changes of BMI and BMIz or risk of overweight between groupsa
| Intervention versus shadow control group | Intervention versus control group | Shadow control versus control group | |||||||
|---|---|---|---|---|---|---|---|---|---|
| n (IG/SG) | β or OR (95% CI) | p value | n (IG/CG) | β or OR (95% CI) | p value | n (SG/CG) | β or OR (95% CI) | p value | |
| BMI (β) | |||||||||
| All | 241/339 | −0.03 (−0.12, 0.06) | 0.50 | 241/236 | 0.07 (−0.02, 0.15) | 0.14 | 339/236 | 0.10 (0.01, 0.19) | 0.03 |
| Completers | 141/339 | −0.05 (−0.16, 0.05) | 0.32 | 141/172 | 0.04 (−0.06, 0.15) | 0.42 | 339/172 | 0.10 (−0.00, 0.20) | 0.06 |
| BMIz (β) | |||||||||
| All | 241/339 | −0.02 (−0.08, 0.05) | 0.62 | 241/236 | 0.04 (−0.02, 0.10) | 0.19 | 339/236 | 0.06 (−0.01, 0.12) | 0.07 |
| Completers | 141/339 | −0.03 (−0.10, 0.04) | 0.41 | 141/172 | 0.03 (−0.05, 0.11) | 0.45 | 339/172 | 0.06 (−0.01, 0.13) | 0.10 |
| Overweight (OR) | |||||||||
| All | 241/339 | 1.06 (0.57, 1.97) | 0.85 | 241/236 | 1.45 (0.73, 2.87) | 0.28 | 339/236 | 1.14 (0.73, 2.56) | 0.33 |
| Completers | 141/339 | 0.86 (0.40, 1.87) | 0.71 | 141/172 | 0.96 (0.41, 2.27) | 0.93 | 339/172 | 1.11 (0.57, 2.18) | 0.75 |
IG, intervention group; CG, control group; SG, shadow control group.
aLinear regression analyses with clustered standard errors performed. Adjusted for baseline measure of outcome, age, sex, and follow-up time.
Among children who completed the Healthy Start intervention, no differences were observed between the intervention and control group in ΔBMI (β = 0.04 [−0.06; 0.15], p = 0.42) or ΔBMIz (β = 0.03 [−0.05; 0.11], p = 0.45) (Table 2) at 2.7 years after the baseline examination. In addition, no difference in the risk of developing overweight were observed between the intervention group and the control group (OR 0.96 [95% CI: 0.41; 2.27] p = 0.93).
Intervention versus Shadow Control Group
Among all children included in the Healthy Start intervention at baseline, no differences were observed between the intervention and shadow control group in ΔBMI (β = −0.03 [−0.12; 0.06], p = 0.50) or in ΔBMIz (β = −0.02 [−0.08; 0.05], p = 0.62) (Table 2). No difference in the risk of developing overweight were observed between the intervention group and the shadow control group (OR 1.06 [95% CI: 0.57; 1.97], p = 0.85).
Among children who completed the Healthy Start intervention, no differences were observed between the intervention and shadow control group in ΔBMI (β = −0.05 [−0.16; 0.05], p = 0.32) or in ΔBMIz (β = −0.03 [−0.10; 0.04], p = 0.41) (Table 2). Similarly, no difference in the risk of developing overweight were observed between the intervention group and the shadow control group (OR 0.86 [95% CI: 0.40; 1.87], p = 0.71).
Discussion
In the present primary overweight prevention intervention study, we did not observe any long-term intervention effects on weight development, despite the observed clinically small effects on body composition found immediately after the intervention [11].
The null-results observed in this study are in accordance with results from previous studies that have examined long-term effects of obesity prevention interventions conducted among children in the preschool age [17–21]. However, a key point that disputes direct comparisons between our study and previous studies is that our sample was restricted to children who had a healthy weight at baseline, as the Healthy Start study continues to be the only primary overweight prevention intervention conducted among children. The focus on healthy weight children ensures that our results reflect actual primary preventive effect estimates, rather than effect estimates where prevention or treatment effects cannot be separated. In this regard, a recently published review on primary prevention of overweight and obesity among children and adolescents found that as much as 75–80% of interventions did not show positive effects, and that intervention effects observed in previous studies may reflect body weight reduction among those with overweight or obesity instead of excessive weight gain prevention among children with healthy weight [9]. So far, two studies have performed secondary analyses to examine differential intervention effects related to initial BMI. In the EU-based IDEFICS study, while weight loss was observed among children with overweight or obesity prior to the intervention, similarly to our findings no primary weight gain prevention of the intervention was observed among children with healthy weight prior to the intervention [22]. Likewise, an intervention for prevention of obesity in child health services in Sweden observed weight loss (reductions in BMIz) among children with overweight at baseline but no intervention effects on changes in BMIz among children with healthy weight at baseline [23].
The participation rate of 21% in the intervention group and the control group may be considered low. However, the fact that obesity prevention interventions have not been restricted to healthy weight children previously leaves us with little knowledge on what participation rates could be expected. In general, parents to healthy weight children may not consider their child’s susceptibility to develop overweight in future as a potential threat to their child’s health and may consequently be less motivated to participate in a primary prevention intervention.
The observed lack of long-term intervention effects related to BMI may be attributed by several factors. We did not observe any intervention effects on BMIz immediately after the intervention [11], and the intervention effects that we observed on body composition immediately after the intervention [11] may not have been strong enough to produce long-term effects on BMIz. In this regard, it may be speculated that there may be long-term effects on body composition which we were not able to examine as these data were not available. The cut-offs applied to define susceptibility may have been weak, which hypothetically could result in effects either not being sufficiently strong to induce overweight or being too strong to prevent overweight from developing. In this regard, risk factors for obesity are clustering, and possibly also interacting, and the true level of susceptibility in our study population may have been underestimated as we were not able to select high-risk children based on obesity risk factors such as genetic variants, maternal excess gestational weight gain, or paternal obesity. Other possible explanations include participant adherence to the intervention, and nonoptimal delivery of the intervention, for example, in terms of intervention intensity.
The importance of having long-term follow-up in child obesity prevention interventions was described more than a decade ago [13]. However, even today the knowledge about sustainable overweight and obesity prevention efforts is limited or absent. Although our results do not provide new evidence on how to prevent childhood overweight and obesity from developing long-term, our results do stress the urgent need for developing and testing sustainable primary obesity prevention interventions that can contribute to maintaining healthy weight among children. Our results also stress the urgent need for developing novel interventions to prevent overweight and obesity in childhood, including but not limited to, testing new modifiable factors additional to diet and physical activity in order to overcome this “evidence of no evidence” that we are currently facing [9]. In order to begin to understand the primary causes of obesity, it may be proposed to keep an open mind by questioning if the factors responsible for developing overweight in a child with healthy weight may not be identical to the factors that should be modified (for example, diet and physical activity) in a weight loss program. Finally, to gain new knowledge on the primary drivers of childhood overweight and obesity, future obesity prevention interventions, for example, in school and institutional settings should allow, already in the planning phase, distinction between primary preventive effects (prevention of development of overweight among those with healthy weight) and secondary preventive effects (treatment among those with overweight or obesity, or prevention of additional weight gain among those with overweight or obesity).
The present study is the first and so far only primary prevention intervention among children [9] and, even though our intervention did not generate positive long-term effects, taking a high-risk approach to primary overweight and obesity prevention should not be discarded in future studies. Rather, more studies are clearly urgently needed in this area. In agreement, we have previously reviewed the literature and concluded that obesity prevention may be more successful when targeting high-risk groups as opposed to general population samples [24]. Future studies may further target children based also on other obesity risk factors, such as children born to women with excess gestational weight gain, or to women smoking during pregnancy. In addition, future studies should consider including novel intervention components [9].
The long follow-up time, allowing us to examine potential sustainable intervention effects, is one of the strengths of our study. Another strength is that we were able to retrieve valid measurements of height and weight development from the Danish National Child Health Register, prompting that retrieval of the long-term follow-up data was nearly complete and more importantly, was not affected by bias related to attrition or willingness to participate. Considering that analyses immediately after the intervention showed beneficial but clinically small effects on body composition, it is a limitation to our study that we could only retrieve information on long-term body mass index changes from national registries, while body composition is not measured routinely at school entry in Denmark. We used computer-based randomization to allocate the eligible children into the three allocation groups prior to inviting them to participate in the study. This approach was chosen for project logistic reasons, but it may have introduced confounding (measured or unmeasured) or selection bias which is another important limitation to our study.
In conclusion, our results showed no long-term effects in preventing healthy weight children from developing. We are still in urgent need of both short- and long-term primary weight gain prevention interventions conducted among healthy weight children to begin understanding what are the primary drivers of childhood overweight and obesity.
Acknowledgments
The authors would like to thank all the families participating in the Healthy Start intervention. The authors would like to thank the family general practitioners for providing data. Finally, the authors would like to thank all the researchers, project staff, and students that helped design and conduct the Healthy Start intervention study.
Statement of Ethics
The Scientific Ethical Committee of the Capital Region in Denmark decided that the project was not a bioethics project, and consequently did not need approval from the Danish Bioethics Committee (journal number H-A-2007-0019). The Danish Data Protection Agency approved the study (journal number: 2015-41-3937). Written informed consent to use the collected data for research purpose was obtained from all parents in the intervention and the control groups. It was not necessary to obtain written informed consent from parents in the shadow control group where information on height and weight was provided by medical records.
Conflict of Interest Statement
The authors have no conflicts of interest to declare.
Funding Sources
This research was funded by grants from the Danish Medical Research Council (Grant No. 271-07-0281), TrygFonden (Grant No. 7984-07), and the Danish Health Foundation (Grant No. 2008B101), all awarded to BLH. The Parker Institute at Bispebjerg and Frederiksberg Hospital was supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Author Contributions
N.J.O. and B.L.H. designed and conceptualized the Healthy Start study and acquired the data. S.C.L. conducted the statistical analyses. N.J.O. wrote the paper, with contributions from S.C.L. and B.L.H. All authors approved the final submitted version of the work.
Funding Statement
This research was funded by grants from the Danish Medical Research Council (Grant No. 271-07-0281), TrygFonden (Grant No. 7984-07), and the Danish Health Foundation (Grant No. 2008B101), all awarded to BLH. The Parker Institute at Bispebjerg and Frederiksberg Hospital was supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Data Availability Statement
Data from the Healthy Start project contains sensitive information and cannot be made publicly available for ethical and legal reasons. Public availability may compromise participant privacy, and this would not comply with Danish legislation (www.datatilsynet.dk). Access to the data requires an application submitted to and subsequently approved by the Steering Committee. Data requests may be sent to Professor Berit L. Heitmann (Berit.Lilienthal.Heitmann@regionh.dk) or the Research Unit for Dietary Studies at the Parker Institute (bfheek@regionh.dk).
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data from the Healthy Start project contains sensitive information and cannot be made publicly available for ethical and legal reasons. Public availability may compromise participant privacy, and this would not comply with Danish legislation (www.datatilsynet.dk). Access to the data requires an application submitted to and subsequently approved by the Steering Committee. Data requests may be sent to Professor Berit L. Heitmann (Berit.Lilienthal.Heitmann@regionh.dk) or the Research Unit for Dietary Studies at the Parker Institute (bfheek@regionh.dk).