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. 2021 Sep 23;2021(9):CD007651. doi: 10.1002/14651858.CD007651.pub3

Burke 1998.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria:
School exclusion criteria:
Student inclusion criteria:
Student exclusion criteria:
Setting: school, home
Age group: children
Gender distribution: females and males
Country/Countries where trial was performed: Australia
Interventions Intervention 1: standard PA and nutrition programme (West Australian Schools Physical Activity and Nutrition project) in 6 schools, which consisted of classroom lessons to establish a rationale, plus 20‐minute fitness sessions daily by means of small‐group activities that allowed for individual fitness levels and provided a range of options by means of progression through graded activities. 4 fitness sessions/week was considered a realistic expectation. The nutrition programme aimed to improve children’s diets by prompting families to review their diet; reducing consumption of fat, sugar, and salt; increasing fibre intake; and creating links between home and school for health promotion. The nutrition programme is built around 4 comic books in which 2 space creatures must discover the dietary habits of humans. It includes a Teachers’ Handbook, a Home‐based Mission Booklet, a Class Activities Booklet, incentives, and a Recipe Booklet that presents recipes written for children by children. Home‐based Missions and Class Activities are combined in activities such as planning a week’s grocery shopping on the basis of advertised prices and in learning strategies to resist peer pressure. The Incentives Booklet includes a progress chart, stickers, and a completion certificate to encourage participation of children and parents. Duration of nutrition class activities aimed for 1 hour/week
Intervention 2: standard West Australian Schools Physical Activity and Nutrition programme plus a PA‐enrichment programme for higher‐risk children in 7 schools, which consisted of incorporating the teacher‐parent‐student triad and allowed PA needs and preferences to be met outside the setting of the whole class. Children kept regular, but not continuous, 7‐day PA diaries, which were used by teachers to identify preferred activities and ways these might be increased in duration or frequency. Teachers and students worked together to establish goals and decide on how these might be attained. Parents were asked to monitor completion of diaries and to encourage increased levels of PA
Comparator: no programme in 5 schools
Duration of intervention: 9 months
Duration of follow‐up: 15 months
Number of schools: 18
Theoretical framework: —
Outcomes BMI
Fitness
Study registration
Publication details Language of publication: English
Funding: non‐commercial funding (supported by a Program Grant from the National Health and Medical Research Council of Australia and by the Australian Rotary Health Research Fund)
Publication status: peer‐reviewed journal
Stated aim for study "In the present study, we therefore aim standard West Australian Schools Physical Activity and Nutrition program to involve higher risk children by means of principles of educational reinforcement, combining an 'enrichment' program with the previously reported..."
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomisation process not reported
Allocation concealment (selection bias) Low risk Comment: all participants were allocated at a single point in time following recruitment, so at time of recruitment, allocation was not known
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: no information given, likely not done
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no information given, likely not done
Incomplete outcome data (attrition bias)
Anthropometrics, Fitness Low risk Comment: outcome data complete
Selective reporting (reporting bias) Unclear risk Comment: no protocol published or trial registry
Cluster RCT ‐ Recruitment bias Unclear risk Comment: no indication participants were registered before randomisation
Cluster RCT ‐ Baseline imbalance Low risk Comment: baseline differences adjusted for in analysis
Cluster RCT ‐ Loss of clusters Low risk Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis Low risk Comment: clustering was accounted for in analysis