Grydeland 2013.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: more than 40 pupils in Grade 6 and located in the 3 or 4 largest towns or municipalities in the 7 counties surrounding the county of Oslo School exclusion criteria: — Student inclusion criteria: all Grade 6 students in 37 included schools Student exclusion criteria: — Setting: school Age group: children/adolescents Gender distribution: females and males Country/Countries where trial was performed: Norway |
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| Interventions |
Intervention: collaboration with school principals, teachers, school health services, and parent committees to increase students' PA during school hours and leisure time, and to reduce screen time. Teachers held 1 structured lecture on energy balance; initiated 10‐minute PA breaks during class at least once/week; hung posters in classrooms; launched active commuting campaigns; distributed fact sheets to parents once per month; and implemented a computer‐tailored programme for students. Each school received an “Activity box” with sports equipment and toys to promote PA during recess Comparator: — Duration of intervention: 20 months Duration of follow‐up: 32 months Number of schools: 37 Theoretical framework: social cognitive theory and socioecological framework |
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| Outcomes | PA duration Sedentary time BMI |
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| Study registration | — | |
| 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 overall goal of the HEalth In Adolescents study was to design, implement, and evaluate a comprehensive, intervention programme to promote healthy weight development among young adolescent schoolchildren (11 to 13 year olds)" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "schools were randomised by simple drawing" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "allocation could not be predetermined" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from publication: "neither participants nor investigators were blinded for condition" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from publication: "neither participants nor investigators were blinded for condition" |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: < 10% loss to follow‐up |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | Low risk | Comment: < 10% loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes in protocol paper reported |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: schools were randomised prior to baseline data collection [author communication] |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: no baseline differences |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |