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

Salmon 2008.

Study characteristics
Methods Study design: cluster‐RCT
Intervention period: 6 months
Follow‐up period (post‐intervention): 1 year (assessments at 6, 12 months post‐intervention)
Differences in baseline characteristics: reported
Reliable outcomes: reported
Protection against contamination: reported
Unit of allocation: class
Unit of analysis: individual
Participants N (controls baseline) = 62
N (controls 12 ‐month follow‐up) = 55
N (behavioural modification (BM) intervention baseline) = 66
N (BM 12‐month follow‐up) = 60
N (fundamental motor skills (FMS) intervention baseline) = 74
N (FMS 12‐month follow‐up) = 69
N (BM/FMS baseline) = 93
N (BM/FMS 12‐month follow‐up) = 84
Setting (and number by study group): 17 classes across 3 schools. Number of classes in each trial group NR
Recruitment: all grade 5 students within 3 selected government schools located across 4 campuses in low‐SES areas
Geographic region: Melbourne, Australia
Percentage of eligible population enrolled: 78%
Mean age: male 10 years 8 months ± 5 months; female 10 years 8 months ± 4 months
Sex: 51% female
Interventions 3 intervention groups:
  • Behaviour modification (BM) group: in addition to the usual PE and sports classes, 19 lessons (40‐50 min each) were delivered in classroom by 1 qualified PE teacher for 1 school year. Lessons incorporated self‐monitoring time spent in PA and screen behaviours, health benefits of PA, sedentary behaviour environments, decision‐making and identifying alternatives to screen behaviours, intelligent TV viewing and reducing viewing time, advocacy of reduced screen time, use of pedometers and group games

  • Fundamental Motor Skills (FMS) group: in addition to the usual PE and sports classes, 19 lessons (40‐50 min each) were delivered either in the indoor or outdoor PA facilities at each school for 1 school year. Lessons focused on mastery of 6 fundamental movement skills (run, throw, dodge, strike, vertical jump, and kick). The interventionist taught the skills with an emphasis on enjoyment and fun through games and maximum involvement for all the children.

  • BM/FMS group: children in this group received both BM and FMS lessons.


PA interventions vs control
Outcomes
  • BMI

  • Overweight/obesity

  • Objectively assessed PA (accelerometer) ‐ PA measured for 8 days during waking hours, except when bathing or swimming

  • Self‐reported screen behaviours

  • Self‐reported enjoyment of PA (5‐point Likert scale)

  • Mastery of fundamental movement skills

  • Body image (5‐point Likert scale) ‐ rate their satisfaction with their body weight and body shape

  • Food intake: children were asked to complete a 22‐item food‐frequency questionnaire to determine the energy density of their diet


Process evaluation: reported
Implementation‐related factors Theoretical basis: SCT and Behavioural Choice theory
Resources for intervention implementation (e.g. funding needed or staff hours required): reported
Who delivered the intervention: reported
PROGRESS categories assessed at baseline: reported (place, gender, education, SES)
PROGRESS categories analysed at outcome: reported (gender)
Outcomes relating to harms/unintended effects: reported
Intervention included strategies to address diversity or disadvantage: reported
Economic evaluation: NR
Notes Funding: this study was funded by the Victorian Health Promotion Foundation. Jo Salmon is supported by a National Heart Foundation of Australia and Sanofi‐Aventis Career Development Award. Kylie Ball is supported by a National Health and Medical Research Council/National Heart Foundation of Australia Career Development Award. David Crawford is supported by a Victorian Health Promotion Foundation Senior Research Fellowship.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by withdrawing a ticket from a container
Allocation concealment (selection bias) Low risk Allocation was by class and all classes were randomised at the start of the study
Blinding (performance bias and detection bias)
All outcomes Low risk The 5 specialist evaluators who examined video tapes of children performing the fundamental movement skills to assess the children's mastery of these skills were blind to the group assignment.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No cluster lost; individual loss 25% overall and similar across groups; generalised estimating equation models were used to account for data missing at random
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 Figure indicates recruitment happened prior to randomisation