Breheny 2020.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: UK schools with at least 20 pupils in school years 3 and 5 School exclusion criteria: none Student inclusion criteria: students in Years 3 (aged 7 to 8 years) and 5 (aged 9 to 10 years) Student exclusion criteria: pupils that had a disability preventing them from running or walking for 15 minutes and those who were unable to have their height and/or weight measured at baseline Setting: school Age group: children Gender distribution: females and males Country where trial was performed: UK |
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| Interventions |
Intervention: The Daily Mile. Each day, the teacher leads the class on a run or walk as fast as they can go in 15 minutes Comparator: usual practice Duration of intervention: 12 months Duration of follow‐up: ‐ Number of schools: 40 Theoretical framework: ‐ |
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| Outcomes | Fitness BMI Health‐related quality of life |
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| Study registration | ISRCTN 12698269 | |
| Publication details |
Language of publication: English Funding: Birmingham City Council Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of this pragmatic cluster RCT is to assess the clinical and cost‐effectiveness of The Daily Mile in Birmingham primary schools for the purpose of improving health and well being" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "an independent statistician used a constrained randomisation based algorithm in a statistical package" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "an independent statistician used a constrained randomisation based algorithm in a statistical package" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from publication: "it was not possible to mask school staff, children, family members and project staff" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from publication: "all research staff undertaking the physical measurements were blinded" |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Quote from publication: "There was a large amount of missing data for the other secondary outcomes. For fitness and academic attainment this exceeded 56% at certain time points and therefore multiple imputation was performed and both complete case and imputed variables are reported" |
| Selective reporting (reporting bias) | Low risk | Comment: all applicable outcomes reported |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: schools enrolled and baseline data collected prior to randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: no baseline differences |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 1 cluster lost from control arm |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |