Roth 2015.
Study characteristics | ||
Methods | Study name: PAKT project Study design: cluster‐RCT Intervention period: 11 months Follow‐up period (post‐intervention): 2‐4 months Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: reported Unit of allocation: preschool Unit of analysis: individual |
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Participants | N (control baseline) = 341 N (control follow‐up) = 289 N (intervention baseline) = 368 N (intervention follow‐up) = 319 Setting (and number by study group): 41 preschools Recruitment: all preschools in the relevant geographical areas were approached, except those with a special focus on PA promotion Geographic region: cities and counties of Wurzburg and Kitzingen, 2 regions in south Germany Percentage of eligible population enrolled: 72% participants Mean age: intervention + control 4.7 ± 0.6; intervention: 4.7 ± 0.7; control: 4.7 ± 0.6 Sex: intervention, 47.6% female; control, 51.6% female |
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Interventions | Aimed to evaluate a multicomponent, child‐appropriate preschool intervention programme led by preschool teachers to enhance PA and motor skill performance in 4‐ and 5‐year‐old children. Daily PA session lasting 30 min and PA homework over 1 academic year. Intervention was designed by professional. Intervention included educational components for parents and teachers. Implementation of the intervention was monitored at least once per 8 weeks. PA intervention vs control |
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Outcomes | Outcome measures
Process evaluation: NR |
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Implementation‐related factors | Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender, SES, race/ethnicity (migrant status) PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: reported (accidents and infections) Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
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Notes | Funding: the authors declare that the institution of household, KCR and KR had financial support from the German Federal Ministry of Education and Research (BMBF) (Grant Nr. 01EL0606, BMBF) and from the BARMER GEK (formerly Gmuender Ersatz‐Kasse GEK) for the submitted project.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Implemented by preschool teachers without further costs |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number table stratified for urban or rural location |
Allocation concealment (selection bias) | Low risk | Randomisation was performed by a person blinded to the identity of the preschool |
Blinding (performance bias and detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 13%‐15% attrition |
Selective reporting (reporting bias) | Unclear risk | Protocol or trial register not found |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figures shows recruitment happened prior to randomisation |