Suchert 2015.
Study characteristics | ||
Methods | Study design: cluster‐RCT | |
Participants |
School inclusion criteria: schools selected from a complete list of all secondary schools in Schleswig Holstein obtained from the Ministry of Education School exclusion criteria: schools for disabled students Student inclusion criteria: all students in participating classes Student exclusion criteria: — Setting: school Age group: adolescents Gender distribution: females and males Country/Countries where trial was performed: Germany |
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Interventions |
Intervention: the intervention operates at 4 levels: individual, class, school, and parents
Comparator: no further intervention Duration of intervention: 12 weeks Duration of follow‐up: 1 year Number of schools: 29 Theoretical framework: — |
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Outcomes | Fitness BMI |
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Study registration | ISRCTN49482118 | |
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 | "The aim of the study is to evaluate the implementation and effectiveness of the “läuft” PA program among adolescents in grade 8" | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from publication: "a stratified randomisation was carried out on the school level (according to type of school and number of participating classes) with the computer program Randomization In Treatment Arms" |
Allocation concealment (selection bias) | Low risk | Comment: randomisation conducted using a computer programme |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants not blinded to intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: assessors were not blinded [author communication] |
Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Quote from publication: "students in the study sample engaged in less out‐of‐school sports activities at baseline than students lost to post‐assessment (P = 0.006). Attrition analyses revealed no further differences. There was no selective attrition between groups" |
Selective reporting (reporting bias) | High risk | Comment: reporting of medical testing listed in protocol missing |
Cluster RCT ‐ Recruitment bias | High risk | Comment: participants recruited after clusters randomised |
Cluster RCT ‐ Baseline imbalance | High risk | Comment: clusters not balanced at baseline |
Cluster RCT ‐ Loss of clusters | Low risk | Comment: there was no dropout on school or class level |
Cluster RCT ‐ Incorrect analysis | Low risk | Comment: analysis accounted for clustered design |