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 |
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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 |
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Outcomes | PA duration Sedentary time |
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Study registration | NTR5676 | |
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 | "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" |