Thivel 2011.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: local public schools School exclusion criteria: — Student inclusion criteria: children in Grade 1 or 2, taking part in standard PE classes offered by the school, not participating in more than 3 hours of extracurricular sports activity/week, free of any known disease, not involved in any other study Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: France |
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| Interventions |
Intervention: PA programme consisted of 120 minutes (2 times for 60 minutes) of supervised physical exercise in addition to 2 hours of PE classes/week. Sessions consisted of a 10‐minute warm‐up followed by psychometric activities and exercises to improve coordination, flexibility, strength, speed, and endurance. Content of the programme was designed to enhance pleasure and enjoyment during exercise, to encourage children’s participation in PA during the intervention, but also to motivate them to maintain an active lifestyle on a long‐term basis. The main objectives of sessions were to increase time spent in PA and to minimise inactivity Comparator: followed their habitual 2 hours of PE/week Duration of intervention: 6 months Duration of follow‐up: 6 months Number of schools: 19 Theoretical framework: — |
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| Outcomes | BMI Fitness |
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| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (governmental organisation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of this study was to explore the effect of a 6‐month school‐based PA intervention on obese and lean children’s body composition and physical fitness" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computer‐generated [author communication] |
| Allocation concealment (selection bias) | High risk | Comment: allocation not concealed [author communication] |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from publication: "children in control group were not aware of intervention group" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome assessors not blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: sample size of 457 from original 650 participants [suthor communication] |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students were enrolled after randomisation [author communication] |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: no baseline differences between groups [author communication] |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost [author communication] |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: clustering not accounted for in analysis |