Jansen 2011.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: schools in more deprived inner‐city areas with high proportions of immigrant children in the city of Rotterdam School exclusion criteria: schools that could not be paired based on size, proportion of migrants, and neighbourhood Student inclusion criteria: Grades 3 to 8 Student exclusion criteria: — Setting: school, urban Age group: children/adolescents Gender distribution: females and males Country/Countries where trial was performed: The Netherlands |
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| Interventions |
Intervention: 4 components: (1) implementation of 3 PE sessions/week by a PE teacher; (2) organisation of additional voluntary sport and play activities outside school hours; (3) classroom education with 3 main lessons on healthy nutrition, active living, and healthy lifestyle choices adapted for each grade. Each lesson finishes with joint goal‐setting, and individual counselling by the school nurse is offered if needed; (4) health promotion gathering at the beginning of the school year for parents and involvement of local sport clubs Comparator: continued with usual curriculum: 2 PE sessions/week by classroom teacher or a PE teacher, dependent on school policy Duration of intervention: 1 school year Duration of follow‐up: 1 school year Number of schools: 20 Theoretical framework: theory of planned behaviour and ecological model |
|
| Outcomes | BMI Fitness |
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| Study registration | ISRCTN84383524 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: — Publication status: peer‐reviewed journal |
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| Stated aim for study | "The purpose of this study was to evaluate the effect of a school‐based intervention program to reduce overweight and improve fitness in primary school children" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "randomisation took place within each pair with the toss of a coin by an officer of the municipal education service" |
| Allocation concealment (selection bias) | Low risk | Comment: randomisation was done with a coin toss; participants could not foresee assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding was not feasible based on nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: blinding was not feasible due to the presence of a PE teacher during PE class in intervention schools |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: very low dropout; missing data not described but were imputed in analysis |
| Selective reporting (reporting bias) | Low risk | Comment: all specified outcomes reported |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: schools were randomised prior to baseline data collection [author communication] |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: baseline differences adjusted for |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 6 clusters lost after randomisation |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: multi‐level analyses were used to allow for clustering of observations within schools |