Simon 2004.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: 8 schools out of 77 public middle‐schools at the Department of Bas‐Rhin (Eastern France) were randomly selected School exclusion criteria: — Student inclusion criteria: all initially first‐level students (corresponding to USA Grade 6) at these schools Student exclusion criteria: — Setting:: community, school, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: France |
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| Interventions |
Intervention: the Intervention Centred on Adolescents’ Physical Activity and Sedentary Behaviour programme was implemented over 4 academic years to promote PA inside and outside. The intervention includes an educational component focusing on PA and sedentary behaviours and new opportunities for PA during school hours (lunch break, recess) and after school hours. Activities implemented are either informal or academic with emphasis on fun and pleasure, well‐being, and non‐competitiveness. Sporting events and bicycle and on‐foot transport are organised, with teachers, parental organisations, and sport associations encouraged to participate in meetings and regular contact. Intervention staff are informed of study objectives and work in collaboration with different partners. The Intervention Centred on Adolescents’ Physical Activity and Sedentary Behaviour coordinators regularly visit intervention school members to inquire about difficulties and to help resolve material or personnel needs Comparator: — Duration of intervention: 40 weeks/y × 4 years Duration of follow‐up: 4 school years Number of schools: 8 Theoretical framework: — |
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| Outcomes | BMI | |
| Study registration | NCT00498459 (registered retrospectively) | |
| Publication details |
Language of publication: English Funding: other funding (Caisse Regionale d’Assurance Maladie d’Alsace Moselle, French National Plan for Nutrition and Health, Institut national de la SNE et de la recherche médicale, Conseil General of the Bas‐Rhin, Communes of Drusenheim, Illkirch‐Graffenstaden, Obernai and Schiltigheim, and Masterfoods) Publication status: peer‐reviewed journal |
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| Stated aim for study | "We wish to assess whether the intervention as implemented has produced a favourable influence on the activity patterns of the adolescents and on different psychological variables related to PA with a particular interest on the interconnection between these variables" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random numbers table [author communication] |
| Allocation concealment (selection bias) | Low risk | Comment: all participants were allocated at a single point in time following recruitment, so at time of recruitment, allocation was not known |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no participants or personnel were blinded other than data analysts [author communication] |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome assessors were not blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: outcome data complete |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported on |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students were recruited after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: groups equal at baseline |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: 2008 paper of complete results; 7/479 and 3/475 were lost for unknown reason; all others due to school transfer |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |