Donnelly 2017.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: elementary schools within a 25‐mile radius of Lawrence, Kansas, including Grades 2 through 5, with at least 40 students in Grades 2 and 3, not participating in other classroom‐based PA interventions, and agreeing to be randomised School exclusion criteria: — Student inclusion criteria: a random sample of Grade 2 and 3 students in each school from those who provided parental consent or child assent Student exclusion criteria: students with physical or intellectual disabilities or learning disorders were part of the intervention or control group as a function of attending the school; however, some were ineligible to complete the outcome assessment due to their disability (i.e. blind, severe intellectual disability, etc.) Setting: school Age group: children Gender distribution: females and males Country where trial was performed: USA |
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| Interventions |
Intervention: teacher‐delivered 10‐minute Academic Achievement and Physical Activity Across the Curriculum lessons twice per day (1 morning and 1 afternoon) 5 days/week plus 60 minutes of PE to total 160 minutes/week of MVPA Comparator: teachers were asked to continue to use traditional classroom instruction and to continue with their typical PE schedule (2‐ to 30‐minute classes/week) Duration of intervention: 3 years Duration of follow‐up: — Number of schools: 17 Theoretical framework: — |
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| Outcomes | BMI Fitness |
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| Study registration | NCT01699295 (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 study is to assess differences in academic achievement in students who receive physically active lessons and students in control schools who receive regular academic lessons. Secondary aims include determining potential mediators of any association between Academic Achievement and Physical Activity Across the Curriculum and academic achievement, including changes in cognitive function, cardiovascular fitness, daily PA, BMI and attention‐to‐task. An extensive process analysis will also be performed to document the fidelity of the intervention" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "computer randomised by study statistician" |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students and teachers not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from publication: "staff completing assessments, other than those obtained in the classroom, and staff performing data entry, were blinded to condition" |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: large loss to follow‐up; no imputation for secondary outcomes |
| Selective reporting (reporting bias) | High risk | Comment: PA not reported |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students recruited after randomisation |
| Cluster RCT ‐ Baseline imbalance | High risk | Comment: baseline differences not controlled for |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: loss of clusters from both groups |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |