Peralta 2009.
Study characteristics | ||
Methods | Study design: RCT Intervention period: 6 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: NR Reliable outcomes: reported Protection against contamination: NR Unit of allocation: child Unit of analysis: child All analyses were performed according to ITT principles |
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Participants | N (controls baseline) = 17 N (controls follow‐up) = 16 N (interventions baseline) =16 N (interventions follow‐up) = 16 Setting (and number by study group): secondary school (N = 1) Recruitment: 7th graders completing < 49 laps using Multistage Fitness Test Geographic region: Australia Percentage of eligible population enrolled: 58% Mean age: 12.5 ± 0.4 years Sex: male only |
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Interventions |
(Combined effects of dietary interventions and PA interventions vs control) |
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Outcomes |
Process evaluation: reported |
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Implementation‐related factors | Theoretical basis: reported (SCT) Resources for intervention implementation (e.g. funding needed or staff hours required): NR Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (gender) PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
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Notes | Funding: the study authors thanked participating students, staff and the broader intervention school community for partly funding the study. All analyses performed according to ITT principles |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised "using a computer‐based number producing algorithm..." |
Allocation concealment (selection bias) | Unclear risk | NR |
Blinding (performance bias and detection bias) All outcomes | Low risk | Assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only one participant lost at follow‐up and ITT done |
Selective reporting (reporting bias) | Unclear risk | Protocol or trial register not found |
Other bias | Low risk | Intervention conducted in 1 school with an absence of a 'true' control group since it was compulsory for all boys to participate in PA |