Vandongen 1995.

Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "… to assess the impact of the programs on cardiovascular risk factors using a modified factorial design to examine fitness and nutrition programs alone and in combination and to compare the effects of school‐based and home‐based nutrition programs" (quote) Study period: recruitment start: beginning of 1990 school year; data collection end date: end of 1990 school year Total number of arms: 6 Description of intervention arms: 1. School and home nutrition program (child + caregiver); 2. School nutrition program (child only); 3. Fitness program (not eligible); 4. Fitness and school nutrition program (not eligible); 5. Home nutrition program (not eligible); 6. No intervention control (not eligible) Number of clusters per arm: 5 Average cluster size: 38.23 children Sample size justification and outcome used: sample size calculations were based on a pilot study in 10 schools with about 300 children. To detect a 5‐lap difference (standard deviation of 14) in the Leger run, with 80% power, an alpha level of 0.05, and allowance for failure to achieve both baseline and follow‐up measurements in around 20% of children, approximately 150 children per arm were needed. If a class size of 30 children was estimated, 30 schools were required Unit of allocation: school Missing data handling: not reported Reported limitations: 1. Girls who did not attend follow‐up tended to be less fit and to have higher blood pressure at baseline than girls who completed the study; 2. The proportion of children exceeding recommended cholesterol levels is probably underestimated because of the measurement instrument used (Reflotron) Randomization ratio and stratification: 1:1:1:1:1:1; stratified by socioeconomic status (each school was assigned to 1 of 5 socioeconomic strata, based on the Australian Bureau of Statistics ratings of postcodes) Participant compensation or incentives: for the child + caregiver arm, children had to bring completed homework to school and were rewarded. The reward was not described
Participants	Baseline characteristics Child + caregiver arm (intervention group) Female (PROGRESS‐Plus): n (%): 65/119 (55) Age in years (PROGRESS‐Plus): not reported Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): not reported 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: body mass index (BMI; kg/m2), mean (SD): 17.82 (3.03) Child diet: total energy (kcal/d), mean (SD): 1638.8 (456.9); % energy from fat, mean (SD): 31.5 (5.2); % energy from saturated fat, mean (SD): 13.0 (2.8); % energy from protein, mean (SD): 15.4 (3.2); sodium (g/d), mean (SD): 2.2 (0.8) 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 (%): 91/164 (55) Age in years (PROGRESS‐Plus): not reported Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): not reported 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: body mass index (BMI; kg/m2), mean (SD): 17.73 (2.42) Child diet: total energy (kcal/d), mean (SD): 1638.8 (449.8); % fat of total energy, mean (SD): 34.1 (5.8); % saturated fat of total energy, mean (SD): 14.0 (2.9); % protein of total energy, mean (SD): 15.3 (3.0) ; sodium (g/d), mean (SD): 2.1 (1.0) 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 Recruitment methods: no information on recruitment of study schools was reported. Within the selected schools, a letter explaining the study and seeking consent was sent to the parents of all children enrolled in sixth grade Inclusion criteria: cluster: not reported; participant: sixth grade student and caregiver Exclusion criteria: not reported Age of participating children at baseline: sixth grade (estimated to be 10 to 12 years old) Total number randomized by relevant group: total across all study arms: n = 1147; samples per arm were not reported and therefore were estimated: child + caregiver arm: n = 229; child‐only arm: n = 229 Baseline imbalances between relevant groups: significant between‐group differences were reported for some baseline variables, but study authors did not specify which variables or between which study arms Total number analyzed by relevant group: child + caregiver arm: n = 119; child‐only arm: n = 164 Attrition by relevant group: attrition was not reported and cannot be calculated as study authors did not report the number of children by intervention arm at baseline Description of sample for baseline characteristics reported above: all children with matched paired diet data (child + caregiver arm: n = 119; child‐only arm: n = 164)
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): school‐and‐home nutrition program Focus of intervention: diet 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," "reward and threat" Why: rationale, theory, or goal (TIDieR #2): this intervention aimed to identify if the effect of combining school‐based and home‐based nutrition education programs was greater than delivering a school‐based program on its own. 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): in addition to the child‐only intervention, children received 5 nutrition messages using comics delivered through schools. Each comic contained material for both child and caregiver Who: providers (TIDieR #5): not reported Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: data on boys and girls were presented separately Assessment time points: baseline, 9 months (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): in addition to child‐only intervention, children received comics containing educational material for the child and other material for caregivers. Additionally, caregivers were encouraged to assist the child with homework exercises, help to prepare healthy recipes, and other unspecified activities. Children received a reward for returning completed homework sheets to school Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported Sensitivity analyses: not reported Child‐only arm (control group) Brief name/description (TIDieR #1): school‐based nutrition program Focus of intervention: diet Behavior change techniques: "shaping knowledge" Why: rationale, theory, or goal (TIDieR #2): the intervention sought to evaluate programs to improve cardiovascular health in schoolchildren. The primary targets of the nutrition interventions were increased intake of fruit, vegetables, whole grain bread, and cereals relative to other foods and decreased intake of fatty, sugary, and salty foods relative to other foods. The nutrition interventions also aimed to achieve intake of ≤ 33% of energy as fat and 12% as sugar while increasing fiber intake to ≥ 25 g/d. 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): ten 1‐hour lessons to improve knowledge, attitudes, and habits around healthy eating were taught to students by classroom teachers Who: providers (TIDieR #5): teachers who received a single half‐day in‐service training and were provided with a program guide Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: data on boys and girls were presented separately Assessment time points: baseline, 9 months (end of intervention) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): teachers were provided with a program guide, videos, and other unspecified teaching resources Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): all teachers attended the in‐service training. No other information was reported regarding adherence and fidelity Sensitivity analyses: not reported
Outcomes	The following instruments were used to measure outcomes relevant to this review at baseline and at 9 months (end of intervention) Children's dietary intake: self‐reported food records from 2 weekdays Available data from the end‐of‐intervention assessment include the following outcomes: total energy intake, percentage energy from fat intake, percentage energy from protein, sodium intake Children's anthropometry: measured height and weight (specific instruments not specified) BMI values were reported for the end‐of intervention assessment. Sex‐ and age‐standardized BMI values were not reported and could not be retrieved Prevalence of overweight or obesity was not reported and could not be retrieved from the study authors Data were analyzed and presented separately for boys and girls. Data also were analyzed by baseline level of cardiovascular risk
Identification	Study name: Western Australian Schools Physical Activity and Nutrition Project (WASPAN) Country: Australia Setting: schools in Perth, Western Australia Types of reports: published journal articles Comments: used the following reports: (1) Vandongen 1995b, and (2) Burke 1996, as well as unpublished information provided by study authors (Gracey 2018 [pers comm]) Author's name: Robert Vandongen; corresponding author Valerie Burke (Gracey) Email: valerie.gracey@optusnet.com.au Conflicts of interest: not reported Sponsorship source: “this study was supported by a Program Grant from the National Health and Medical Research Council (Public Health Research and Development Committee)” (quote)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation	Low risk	Judgment comment: within socioeconomic strata, schools were randomly allocated via computer‐generated random numbers (Gracey 2018 [pers comm])
Allocation concealment	Unclear risk	Judgment comment: methods used to conceal the allocation sequence were not described
Blinding of participants and personnel All outcomes	Unclear 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 10 to 12 years, and their performance may or may not have been influenced by lack of blinding
Blinding of outcome assessment All outcomes	Unclear risk	Quote: "restricted funding and limited availability of qualified personnel prevented the use of a team of assessors who were blinded to the intervention" (Vandongen 1995b, p 11) Judgment comment: data on dietary intake (our primary outcome) was measured by children's self‐report and may or may not have been influenced by lack of blinding
Incomplete outcome data All outcomes	Unclear risk	Quote: “dietary data at follow‐up were obtained from 83% of children, fitness data from 88%, blood pressure data from 96%, cholesterol levels from 96%, and anthropometry from 92%” (Vandongen 1995b, p 11) Judgment comment: however, attrition rates by intervention arm were not reported and could not be calculated because the study authors did not report the number of children by intervention arm at baseline
Selective reporting	Unclear risk	Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Following conversions of reported data, we were able to enter them into meta‐analysis
Recruitment bias	Unclear risk	Judgment comment: it is unclear whether participants were recruited before or after randomization
Baseline imbalance	High risk	Quote: "…there were significant between‐group differences in some baseline variables" (Vandongen 1995b, p 11) Judgment comment: study authors did not report on similarities and differences between clusters
Loss of clusters	Unclear risk	Judgment comment: study authors did not report whether any clusters were lost
Incorrect analysis	High risk	Judgment comment: study authors did not report adjusting for clustering in the analysis and did not report intraclass correlation coefficients (ICCs)
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