Salmon 2008.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 6 months Follow‐up period (post‐intervention): 1 year (assessments at 6, 12 months post‐intervention) Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: reported Unit of allocation: class Unit of analysis: individual |
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Participants | N (controls baseline) = 62 N (controls 12 ‐month follow‐up) = 55 N (behavioural modification (BM) intervention baseline) = 66 N (BM 12‐month follow‐up) = 60 N (fundamental motor skills (FMS) intervention baseline) = 74 N (FMS 12‐month follow‐up) = 69 N (BM/FMS baseline) = 93 N (BM/FMS 12‐month follow‐up) = 84 Setting (and number by study group): 17 classes across 3 schools. Number of classes in each trial group NR Recruitment: all grade 5 students within 3 selected government schools located across 4 campuses in low‐SES areas Geographic region: Melbourne, Australia Percentage of eligible population enrolled: 78% Mean age: male 10 years 8 months ± 5 months; female 10 years 8 months ± 4 months Sex: 51% female |
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Interventions | 3 intervention groups:
PA interventions vs control |
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Outcomes |
Process evaluation: reported |
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Implementation‐related factors | Theoretical basis: SCT and Behavioural Choice theory Resources for intervention implementation (e.g. funding needed or staff hours required): reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (place, gender, education, SES) PROGRESS categories analysed at outcome: reported (gender) Outcomes relating to harms/unintended effects: reported Intervention included strategies to address diversity or disadvantage: reported Economic evaluation: NR |
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Notes | Funding: this study was funded by the Victorian Health Promotion Foundation. Jo Salmon is supported by a National Heart Foundation of Australia and Sanofi‐Aventis Career Development Award. Kylie Ball is supported by a National Health and Medical Research Council/National Heart Foundation of Australia Career Development Award. David Crawford is supported by a Victorian Health Promotion Foundation Senior Research Fellowship. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by withdrawing a ticket from a container |
Allocation concealment (selection bias) | Low risk | Allocation was by class and all classes were randomised at the start of the study |
Blinding (performance bias and detection bias) All outcomes | Low risk | The 5 specialist evaluators who examined video tapes of children performing the fundamental movement skills to assess the children's mastery of these skills were blind to the group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No cluster lost; individual loss 25% overall and similar across groups; generalised estimating equation models were used to account for data missing at random |
Selective reporting (reporting bias) | Unclear risk | Protocol or trial register not found |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figure indicates recruitment happened prior to randomisation |