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. 2021 Sep 23;2021(9):CD007651. doi: 10.1002/14651858.CD007651.pub3

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
Interventions Intervention: the intervention operates at 4 levels: individual, class, school, and parents
  • Student: pedometer use, interactive user account on the "läuft" homepage

  • Class: competitions, educational and practical resources

  • School: informational material, introductory seminar for participating teachers

  • Parent: informational material, parent‐teacher conference


Comparator: no further intervention
Duration of intervention: 12 weeks
Duration of follow‐up: 1 year
Number of schools: 29
Theoretical framework: —
Outcomes Fitness
BMI
Study registration ISRCTN49482118
Publication details Language of publication: English 
Funding: non‐commercial funding (charitable trust)
Publication status: peer‐reviewed journal
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