Madsen 2015.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: > 50% of students eligible for free or reduced‐price lunch; average of at least 60 students/grade; no exposure to Playworks in the past 5 years School exclusion criteria: — Student inclusion criteria: all Grade 3, 4, and 5 students from the 6 participating schools Student exclusion criteria: — Setting: school, urban Age group: — Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention: each intervention school received 1 part‐time registered dietician coach and 1 full‐time Playworks coach for 2 school years. Each year, the registered dietician coach delivered a 12‐week nutrition and energy balance education curriculum that included food tasting, PA games to reinforce nutrition messages, and strategies to help students meet their nutrition and PA goals. Registered dietician coaches also worked with a team of school staff and parents to implement classroom wellness policies and to make improvements in school food, including increased offerings of fruits and vegetables to meet the Bronze‐level Healthier USA School Challenge criteria. The Playworks coach structured recess activities before and during school hours to encourage active participation by all students. The Playworks coach also led a PA session with individual classes every other week. Classroom teachers were trained to implement Playworks games and classroom management strategies in their PE sessions with students. Last, Playworks coaches led after‐school sports leagues throughout each year Comparator: — Duration of intervention: 2 years Duration of follow‐up: 2 years Number of schools: 6 Theoretical framework: social cognitive theory |
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| Outcomes | Fitness BMI |
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| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (charitable trust) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The current study was designed to test the impact of Energy Balance 4 Kids with Play on students’ nutrition and PA knowledge and behaviours, fitness, and BMI z‐score over a 2‐year period beginning in the fall of 2011" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random number generator [author communication] |
| Allocation concealment (selection bias) | High risk | Comment: 1 school knowingly assigned to intervention group |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no blinding [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: missing data explained; similar between groups |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in protocol paper |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: baseline data collected after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: differences adjusted for in analyses |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters were lost [author communication] |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "mixed‐effects linear regression models were used ...[with] school as a random effect to account for clustering" |