Have 2018.
Study characteristics | ||
Methods | Study design: cluster‐RCT | |
Participants |
School inclusion criteria: schools in Danish municipalities that did not have a structured programme that incorporated PA in the classroom School exclusion criteria: — Student inclusion criteria: — Student exclusion criteria: physical disability, no written parental consent Setting: school Age group: children Gender distribution: females and males Country where trial was performed: Denmark |
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Interventions |
Intervention: classroom‐based PA incorporated into math lessons for 1 school year. Subjects received an average of 6 math lessons of 45 minutes/week. Each lesson included at least 15 minutes of PA, with limited sedentary time. Teachers attended a series of workshops to provide them with the skills to implement task‐relevant physical activity into math teaching Comparator: children in control schools received regular classroom instruction, also with an average of 6 math lessons of 45 minutes/week. Math teachers in the control schools were asked not to make any changes to their usual teaching methods before study endpoint measurements Duration of intervention: 10 months Duration of follow‐up: 10 months Number of schools: 12 Theoretical framework: theory of embodied cognition |
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Outcomes | PA duration BMI |
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Study registration | NCT02488460 (retrospectively registered) | |
Publication details |
Language of publication: English Funding: non‐commercial funding (charitable trust) Publication status: peer‐reviewed journal |
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Stated aim for study | "We designed a randomised controlled trial with the primary objective of investigating how math achievement was affected by task‐relevant PA incorporated into math teaching for 7‐year‐old school children" | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from publication: "randomisation was performed by random selection of sealed envelopes containing the intervention allocation stratified by municipality, in the presence of school leaders, municipality representatives and study researchers" |
Allocation concealment (selection bias) | Low risk | Quote from publication: "randomisation was performed by random selection of sealed envelopes containing the intervention allocation stratified by municipality, in the presence of school leaders, municipality representatives and study researchers" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from publication: "the research assistants were blinded to the randomisation result for measurement of the outcomes and for data entry" |
Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Quote from publication: "during the 9‐month intervention period, the dropout rate was 13.7% in the control group and 8.8% in the intervention group, which was not statistically significant. Dropouts were mainly attributed to subjects not present at follow‐up trials due to sickness or moving to a different city as well as subjects not being able to complete the test due to injury (e.g. the fitness test)" |
Incomplete outcome data (attrition bias) Physical activity and sedentary time | Low risk | Quote from publication: "during the 9‐month intervention period, the dropout rate was 13.7% in the control group and 8.8% in the intervention group, which was not statistically significant. Dropouts were mainly attributed to subjects not present at follow‐up trials due to sickness or moving to a different city as well as subjects not being able to complete the test due to injury (e.g. the fitness test)" |
Selective reporting (reporting bias) | Low risk | Comment: all main outcomes reported |
Cluster RCT ‐ Recruitment bias | Low risk | Comment: all baseline data were measured prior to randomisation [author communication] |
Cluster RCT ‐ Baseline imbalance | Low risk | Quote from publication: "there were no significant differences at baseline between intervention and control group in any descriptive characteristics except height" |
Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "because of the clustered nature of the data, schools were included as random effects in the analyses and the Kenward‐Roger degrees of freedom approximation was used" |