Lazaar 2007.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 6 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: school Unit of analysis: individual |
|
Participants | N (obese: controls baseline) = 41 N (obese: controls follow‐up) = NR* N (non‐obese: controls baseline) = 187 N (non‐obese: controls follow‐up) = NR* N (obese: interventions baseline) = 59 N (obese: interventions follow‐up) = NR* N (non‐obese: interventions baseline) = 138 N (non‐obese: interventions follow‐up) = NR* *Data at 6 months collected from 98.9% of study participants overall. Numbers were NR by group. Setting (and number by study group): school (intervention N = 14; control N = 5) Intervention and control groups were further divided into obese (BMI > 97 th percentile) and non‐obese children to give a total of 4 trial groups (2 x intervention and 2 x control) Recruitment: children from participating local state schools were eligible if they were in their 1st or 2nd grade of elementary school, participating in the scheduled school PE classes, participating in < 3 h of extra‐school sports activity/week, free of any known disease and not participating in other studies. Geographic region: France Percentage of eligible population enrolled: NR Mean age: 7.4 ± 0.8 years (NR by group) Sex: 50% female (NR by group) |
|
Interventions | Control: all children took part in scheduled school PE classes:
Intervention: children in the intervention group were required to follow an additional PA programme:
PA interventions vs control |
|
Outcomes |
Process evaluation: reported |
|
Implementation‐related factors | Theoretical basis: NR Resources for intervention implementation (e.g. funding needed or staff hours required): NR Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (gender) PROGRESS categories analysed at outcome: reported (gender) Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
|
Notes | Funding: this study was supported by grants from French National Plan for Nutrition and health (PNNS), the Comité Régional Exécutif des Actions de Santé d’Auvergne (CREAS),the Caisse Régionale d’Assurance Maladie d’Auvergne (CRAMA), the Appert Institutes, the town of Clermont‐Ferrand and schools’ governing bodies of Clermont‐Ferrand | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A draw was carried out to choose intervention schools |
Allocation concealment (selection bias) | Low risk | All eligible children from within schools were automatically assigned to groups based according to school assignment and based on their individual BMI |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | NR |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only report total (N = 425), and group numbers (138; 59; 187; 41) once in text, so unclear if these were analysed or randomised numbers. supplementary data in tables also have no numbers. |
Selective reporting (reporting bias) | Unclear risk | No protocol available; no tables visible ‐ link does not work; text indicates that post hoc analyses were conducted but these are not listed in the methods. Outcomes for zBMI are presented only for post hoc subgroup analyses (gender, baseline obesity). Main group differences are not presented |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Unclear risk | NR: no consort figure in the paper or refereed to as supplementary file |