Wang 2008.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: elementary schools in Augusta, Georgia School exclusion criteria: — Student inclusion criteria: all Grade 3 students attending the 9 intervention schools were invited to enrol in the FitKid Project free of charge Student exclusion criteria: — Setting: school, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention: the 'FitKid' after‐school programme was offered 5 days/week (not offered during holidays and vacation periods). Certified school teachers and paraprofessionals implemented the programme, following established guidelines that included reinforcement and teaching techniques, safety measures, evaluation procedures, and monthly activity plans that accommodate local weather conditions (i.e. more outdoor‐based activities in spring, winter, and late fall, and more indoor activities in summer and early fall, when it is often too hot and humid to play outside). 2‐hour intervention sessions began with a 40‐minute period during which youths were provided a healthy snack and academic enrichment activities. Snacks were provided through the US Department of Agriculture's National School Lunch and Child and Adult Care Food Programs in cooperation with the school nutrition service. Academic enrichment activities were incorporated into the programme to ensure that participation in the FitKid intervention during after‐school hours would not damage the academic progress of children. The 80 minutes of PA included a variety of activities designed to improve sport skills, aerobic fitness, strength, and flexibility; 40 minutes was devoted to vigorous PA Comparator: — Duration of intervention: 3 school years Duration of follow‐up: 3 years Number of schools: 18 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 (National Institutes of Health) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The objective of this study was to evaluate the cost‐effectiveness of the Medical College of Georgia FitKid Project, a 3‐year, after‐school program designed to prevent obesity among elementary school students" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "schools then were randomised within strata to control or experimental arms of the project using a random number table" |
| 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: students were notified of intervention status |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information given; likely not done |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: incomplete outcome data; not adequately addressed |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported on |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: schools randomised before participants enrolled; some students notified of intervention assignment prior to recruitment |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: adjusted for baseline differences |
| Cluster RCT ‐ Loss of clusters | Unclear risk | Comment: no information given |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |