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

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)
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
Interventions
  • Intervention was designed to change the school environment to promote healthy eating and PA during school and in after‐school care.

  • Daily PA (30 min per child) was integrated into regular school curriculum and facilitated by classroom teachers

  • Classroom teachers encouraged healthy eating, eating less sweetened foods, and to choose healthy items for school lunch and afternoon snack (provided by schools)

  • School changes in items provided to increase health (lower sugar, more fibre, lower fat etc), eliminate unhealthy celebration foods and restrict foods for excursions and sports days

  • Awareness raising activities included STOPP newsletter to parents and schools twice a year

  • School nurses were also trained in obesity‐related problems


Combined effects of dietary interventions and PA interventions vs control
Outcomes
  • Prevalence overweight/obese

  • PA, accelerometer

  • Eating habits


Process evaluation: reported
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
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