Siegrist 2013.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: primary schools throughout Bavaria, Germany School exclusion criteria: none Student inclusion criteria: attendance in Grade 2 or 3 and written consent from parents Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: Germany |
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| Interventions |
Intervention: the focus of the multi‐faceted JuvenTUM intervention was on directly educating and encouraging children, teachers, and parents to live active and healthy lifestyles. Additionally, school environmental settings (e.g. physical environment, organisation of school breaks, playing during school time, sports facilities) were altered to promote more PA. http://www.juventum.med.tum.de/ Comparator: principals were instructed to continue with school activities as usual, without changing policies related to PA or nutrition during the study period Duration of intervention: 1 year Duration of follow‐up: 1 year Number of schools: 8 Theoretical framework: — |
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| Outcomes | BMI | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (governmental organisation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of the present project was to evaluate a simple and ubiquitously applicable school‐based educational program to increase PA, fitness, and lifestyle awareness and to improve health obesity measures" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: schools randomised by drawing a lot [author communication] |
| Allocation concealment (selection bias) | Low risk | Comment: allocation was concealed, and recruitment was based on willingness to be randomised to either group [author communication] |
| 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 | Low risk | Comment: outcome assessors were not aware of group allocation [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: children with missing data were ill or were absent from school or had left school |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available or trial registered |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: individual students enrolled after randomisation at school level [author communication] |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: intervention and control schools were comparable with regard to socioeconomic status of the population and recreational environments |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: analysis did not account for cluster design |