Sutherland 2017.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: government or Catholic elementary schools; located within Hunter New England Local Health District; socioeconomic score ≤ 5 (lower 50% of New South Wales) based on school post code; not participating in other PA studies School exclusion criteria: — Student inclusion criteria: Grades 3 to 6 Student exclusion criteria: major physical or intellectual conditions impeding engagement in PA Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: Australia |
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| Interventions |
Intervention: a modified version of the Supporting Children’s Outcomes using Rewards, Exercise and Skills programme consisting of school committees and policy review, quality PE lessons, recess and lunchtime activity via student leadership, provision of equipment, and linkage with parents and community sporting organisations Comparator: measurement components of the trial only; school PA practices according to curriculum Duration of intervention: 6 months Duration of follow‐up: 6 months Number of schools: 46 Theoretical framework: social‐ecological theory and health promoting schools framework |
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| Outcomes | PA duration | |
| Study registration | ACTRN12615000437561 (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 primary aim of this paper is to report the effectiveness of an adapted version of an evidence based school PA program known as Supporting Children’s Outcomes using Rewards, Exercise and Skills on children’s MVPA. Secondary trial outcomes describe the impact on school implementation of practices including PE teaching quality and school PA practices" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "schools underwent stratified randomisation based on SES, allocated in a 1:1 ratio to intervention or control by an independent statistician using computerized random number function in Microsoft Excel" |
| Allocation concealment (selection bias) | High risk | Comment: random allocation of schools to group occurred post recruitment but before data collection |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: personnel delivering intervention blinded; primary outcome assessment concealed from participants, so lack of blinding of participants unlikely to affect outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors blinded |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | Unclear risk | Comment: no mention of missing data at end of study |
| Selective reporting (reporting bias) | Low risk | Comment: trial protocol referenced |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: participants recruited before cluster randomisation |
| Cluster RCT ‐ Baseline imbalance | Unclear risk | Comment: no analysis of clusters for similarity |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 1 cluster lost after randomisation; no reason given |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: statistical analysis accounted for clustering |