Foster 2008.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 2 years Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported (anthropometry, dietary intake, PA and sedentary behaviour) Protection against contamination: all schools were under the direction of the district's Food Service Division, which agreed to make the necessary changes in intervention schools, while making no changes to the control schools. Unit of allocation: school Unit of analysis: individual Study authors imputed missing data using the multiple imputation procedure with the Markov chain Monte Carlo algorithm as well as the LOCF method for comparison |
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Participants | N (controls baseline) = 600 N (controls follow‐up) = 365 N (interventions baseline) = 749 N (interventions follow‐up) = 479 Setting (and number by study group): schools (N = 5 intervention, N = 5 control) Recruitment: within schools, written parental consent and child assent required Geographic region: Philadelphia, USA Percentage of eligible population enrolled: school level: 83%. Across participating schools, consent rate was 70% ± 15% Mean age: intervention, 11.13 ± 1 years; control, 11.2 ± 1 years Sex: intervention, 52% female; control: 55% female |
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Interventions | SNPI‐School Nutrition Policy Initiative ‐ 5 components School self assessment
Nutrition education
Nutrition policy
Social marketing
Family/parent outreach
Staff training
Combined effects of dietary interventions and PA interventions vs control |
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Outcomes |
Process evaluation: NR |
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Implementation‐related factors | Theoretical basis: settings‐based approach; CDC Guidelines to Promote Lifelong Healthy Eating and PA Resources for intervention implementation (e.g. funding needed or staff hours required): NR Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (race, gender, SES) PROGRESS categories analysed at outcome: reported (race, gender) 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: this study was supported by grants from the CDC (R06/CCR321534‐01) and the US Department of Agriculture/Food and Nutrition Service through the Pennsylvania Nutrition Education Program as part of Food Stamp Nutrition Education | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | NR Quote: "the schools were randomly assigned as intervention or control schools." |
Allocation concealment (selection bias) | Unclear risk | NR Quote: "Schools within each cluster were approached to participate in a predetermined, random order. When 2 schools in each cluster agreed to participate, the schools were randomly assigned as intervention or control schools." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Heights and weights were measured annually on a digital scale and wall‐mounted stadiometer by a trained research team with a standardised protocol. The team was not blinded to treatment condition. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Clusters not lost and individual dropout NR but they did imputations and sensitivity analysis. Quote: "To account for attrition at the student level, we imputed missing data at year 2 using the multiple imputation (MI) procedure with the Markov chain Monte Carlo algorithm.....In addition, to assess the consistency of our findings, data were analysed using the more conventional baseline carried forward and last observation carried forward methods." |
Selective reporting (reporting bias) | Unclear risk | Protocol/trial registration document were unavailable |
Other bias | Low risk | No additional threats to validity. |
Other bias‐ timing of recruitment of clusters | Low risk | Recruitment happened before randomisation. Quote: "Schools within each cluster were approached to participate in a predetermined, random order. When 2 schools in each cluster agreed to participate, the schools were randomly assigned as intervention or control schools." |