Jago 2014.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: primary schools in the Greater Bristol area School exclusion criteria: — Student inclusion criteria: all Year 5 and 6 children who are physically able to engage in PE classes Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: UK |
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| Interventions |
Intervention: Action 3:30 school PA sessions. The focus of the sessions was to promote children’s perceptions of autonomy, belonging, and competence. Amongst a range of techniques, to promote autonomy, teaching assistants were encouraged to provide children with choices within activities, such as leading warm‐ups and adapting games, and there were child‐led sessions in which children chose the activities. Teaching assistants supported competence by setting progressive activities targeting quick successes balanced with providing optimal challenge and providing specific praise for attempts as well as outcomes. Relatedness was supported through empathic teaching assistant‐child interactions, with teaching assistants showing interest in the children’s lives outside the intervention and encouraging teamwork Comparator: schools provided data at Time 0, Time 1, and Time 2 only; no other contact was made by the research team Duration of intervention: 20 weeks Duration of follow‐up: 9 months Number of schools: 20 Theoretical framework: self‐determination theory |
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| Outcomes | PA duration | |
| Study registration | ISRCTN58502739 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The main research question for a future definitive trial is, ‘Is Action 3:30, an after‐school PA intervention that is based on behaviour‐change theory and delivered by teaching assistants, effective in improving the PA, attitudes and confidence of Year 5 and 6 children?’ Specific aims: 1) Estimate the likely recruitment, attendance, and retention rates of pupils to the Action 3:30 after school PA intervention. 2) Estimate the likely impact on PA while the club was still running and 4 months after contact sessions had ended. 3) Develop a reliable costing tool and assess the feasibility of obtaining programme cost data. 4) Estimate the sample size for an adequately powered evaluation of the Action 3:30 intervention" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "randomisation was conducted by an independent statistician in the trials unit with no other involvement in the project" |
| Allocation concealment (selection bias) | Low risk | Comment: conducted by clinical trials unit not involved in the study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students and staff not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: attempted to blind data collectors, but group allocation was often revealed by students or staff [author communication] |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | Low risk | Comment: small loss to follow‐up; reasons provided |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes in protocol paper reported |
| Cluster RCT ‐ Recruitment bias | Low risk | Quote from publication: "schools were randomly assigned to intervention or control arms once baseline data had been processed" |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: models adjusted for baseline imbalance |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "models [used]... robust standard errors used to take account of the cluster randomised design" |