Seibert 2019.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: 40% or more of students qualifying for free or reduced lunch School exclusion criteria: — Student inclusion criteria: Grades 3 to 8 Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country where trial was performed: USA |
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| Interventions |
Intervention: implementation of 3 Centre for Disease Control‐recommended evidence‐based strategies: (1) increasing the amount of time spent in MVPA during PE classes, (2) encouraging active classroom breaks, (3) providing organised PA opportunities during recess, and (4) providing organised PA opportunities before and after school Comparator: continued with prior routine PA programming Duration of intervention: 1 school year Duration of follow‐up: 1 school year Number of schools: 49 Theoretical framework: — |
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| Outcomes | Fitness | |
| Study registration | NCT02411552 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: University of Wisconsin‐MadisonWisconsin Partnership Program and NIH T32 DK077586 Publication status: peer‐reviewed journal |
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| Stated aim for study | "In this study we evaluated the feasibility and effects of a large‐scale implementation program for CDC‐recommended school based physical activity strategies on cardiovascular fitness measured by the Progressive Aerobic Cardiovascular Endurance Run in low SES Wisconsin schools" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: principals and PE educators informed of intervention status |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: schools completed PACER as part of their regular PE class and submitted data to researchers |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Unclear risk | Comment: not described |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes listed in clinical trials registry reported |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: data collected after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: between‐group differences at baseline adjusted for in analysis |
| Cluster RCT ‐ Loss of clusters | Unclear risk | Comment: not described |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "linear mixed effects modelling with school‐specific random effects were conducted to perform the comparisons of outcome measures at baseline between the 2 study arms" |