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

Ten Hoor 2018.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria: Dutch secondary schools
School exclusion criteria:
Student inclusion criteria:
Student exclusion criteria:
Setting: school
Age group: children/adolescents
Gender distribution: females and males
Country where trial was performed: The Netherlands
Interventions Intervention: strength training exercises during at least 30% of regular PE lessons, ~ 5 to 30 minutes/lesson. Teachers were instructed about the programme and specific strength exercises and safety guidelines, participated in workshops to improve their motivational speaking skills, were provided with materials (medicine balls, elastic bands, and free weights), and received a book with strength exercises and games. Once a month, a 1‐hour lesson based on motivational interviewing and facilitated by a trained mentor or PE teacher was used to increase motivation to be more physically active 
Comparator: continued with  usual curriculum
Duration of intervention: 1 year
Duration of follow‐up: 1 year
Number of schools: 9
Theoretical framework: theory of planned behaviour or reasoned action approach, self‐determination theory, social comparison theory, intervention mapping
Outcomes PA duration
Sedentary time
Study registration NTR5676 
Publication details Language of publication: English
Funding: non‐commercial funding (research funding body)
Publication status: peer‐reviewed journal
Stated aim for study "In this cluster RCT, we investigated the 1‐year efficacy of incorporating strength exercises into gym classes, in combination with monthly motivational lessons (to engage in PAs after school) on the body composition and activity level of adolescents"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from publication: "randomised (stratified on education level; by flip of a coin by the first author under supervision of the fourth author) into an intervention condition (4 schools) or a standard curriculum control condition (5 schools)"
Allocation concealment (selection bias) Low risk Comment: allocation concealed from schools or directors; informed that they may or may not receive the intervention immediately [author communication]
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: not possible [author communication]
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: not possible [author communication]
Incomplete outcome data (attrition bias)
Physical activity and sedentary time High risk Comment: 26% to 28% loss to follow‐up
Selective reporting (reporting bias) High risk Comment: strengths listed in clinical trials registry but not reported
Cluster RCT ‐ Recruitment bias High risk Comment: students were enrolled and baseline data collected after school randomisation [author communication]
Cluster RCT ‐ Baseline imbalance Low risk Quote from publication: "no baseline differences were found between the 2 conditions in age, height, weight, BMI (Z‐score), body composition, or PA outcomes (including wear time of the accelerometer)"
Cluster RCT ‐ Loss of clusters Low risk Comment: no loss of clusters
Cluster RCT ‐ Incorrect analysis Low risk Quote from publication: "the random (variance) model part consisted of an unstructured covariance matrix for the within‐school variances and covariance of the 2 repeated measures plus a random intercept for the between‐school outcome variance"