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. 2019 Jul 23;2019(7):CD001871. doi: 10.1002/14651858.CD001871.pub4

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
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
Interventions SNPI‐School Nutrition Policy Initiative ‐ 5 components
School self assessment
  • Assessed environments using the CDC School Health Index

  • School formed a Nutrition Advisory Group to guide assessment

  • Schools subsequently developed an action plan for change with a variety of strategies, e.g. limiting use of food as reward/punishment, fundraising etc


Nutrition education
  • 50 h of food and nutrition education/student/school year based on National Center for Education Statistics guidelines

  • Integrated into classroom subjects; integrative and interdisciplinary


Nutrition policy
  • All food sold and served in the schools was changed to meet the nutritional standards based on dietary guidelines for Americans


Social marketing
  • Several techniques: raffle tickets; slogan and character development


Family/parent outreach
  • Home and school association meetings, report card nights, parent education meetings, weekly nutrition workshops. Parent challenges re PA and healthy eating.

  • Schools encouraged parents to send healthy foods and discouraged unhealthy foods


Staff training
  • All school staff offered ~10 hours/year of training in nutrition education to receive curricula and supporting materials e.g. Planet Health and Know your body, and curriculum lesson packets etc


Combined effects of dietary interventions and PA interventions vs control
Outcomes
  • Incidence of overweight and obesity

  • Prevalence and remission of overweight and obesity

  • Dietary intake and PA

  • Sedentary behaviours

  • Potential adverse effects


Process evaluation: NR
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
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."