Marcus 2009.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 4 years Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported (anthropometry and accelerometry) Protection against contamination: NR Unit of allocation: school Unit of analysis: child. Primary analysis used observed cases, but sensitivity analyses were carried out using FAS population (evaluated with replacement for missing data by LOCF) |
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Participants | N (controls baseline) = 1465 N (controls follow‐up) = 1300 N (interventions baseline) = 1670 N (interventions follow‐up) = 1538 Setting: schools (N = 5 intervention, N = 5 control) Recruitment: all consenting students in selected schools up to 4th school year Geographic region: Sweden Percentage of eligible population enrolled: 90%‐100% Mean age: control: 7.5 (1.3) years; intervention: 7.4 (1.3) years Sex: both sexes included |
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Interventions |
Combined effects of dietary interventions and PA interventions vs control |
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Outcomes |
Process evaluation: reported |
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Implementation‐related factors | Theoretical basis: NR Resources for intervention implementation (e.g. funding needed or staff hours required): NR Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (place, race, occupation, gender, education, social status) PROGRESS categories analysed at outcome: reported (gender, education) Outcomes relating to harms/unintended effects: reported Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
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Notes | Funding: the study was supported by grants from Stockholm County Council, Swedish Council for working life and social research, Swedish Research Council, Freemason’s in Stockholm Foundation for Children’s Welfare and Signhild Engkvist Foundation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Five of the selected schools were thereafter randomized to intervention and five schools to control." |
Allocation concealment (selection bias) | Unclear risk | NR |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | NR |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Figure 1 indicates all randomised (FAS) included in a sensitivity analysis ‐ data not presented, these results were not different. Quote: "The primary analysis was carried out using the observed cases population, and a sensitivity analysis was performed using the FAS population. The FAS population was evaluated with replacement for missing data by the last observation carried forward approach, i.e. where only one measurement was observed, and the estimated change in BMIsds was set to 0." |
Selective reporting (reporting bias) | Low risk | Protocol/trial registration document seen. All outcomes reported |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figure shows recruitment happened prior to randomisation |