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

Magnusson 2011.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria: 3 pairs of schools in the city of Reykjavik were selected and matched for size (i.e. number of students and total number of grades, with at least 30 students entering Grade 2 in 2006)
School exclusion criteria:
Student inclusion criteria: all children attending Grade 2
Student exclusion criteria:
Setting: school
Age group: children
Gender distribution: females and males
Country/Countries where trial was performed: Iceland
Interventions Intervention: students had opportunities to engage in PA during PE lessons, during recess, and during classes where PA was to be integrated into various subjects of the general curriculum. Teachers at intervention schools were provided access to PA equipment intended to be used during regular school lessons. Teaching materials promoting PA, such as books and DVDs on classroom workouts and cooperative activity games, etc., were provided. After the first year of intervention, an additional PE lesson was introduced at the intervention schools. PE teachers at each of the intervention schools carried out this additional lesson, which was specifically tailored to suit all children while maintaining a high level of intensity
Comparator: followed general PA curriculum, compulsory on a national level, consisting of two 40‐minute PE sessions/week, in addition to 2 swimming lessons/week, taught over the course of a 6‐week period any time during the school year
Duration of intervention: 2 years
Duration of follow‐up: 2 years
Number of schools: 6
Theoretical framework: social cognitive theory
Outcomes BMI
Fitness
PA duration
Study registration
Publication details Language of publication: English
Funding: non‐commercial funding (research funding body)
Publication status: peer‐reviewed journal
Stated aim for study "The objectives of this study were to compare changes in volume and intensity of PA among the group of intervention children to PA levels of children who only received general curriculum‐based PA (controls) and further, to assess whether the intervention effect on PA was modified by gender or BMI"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: not described
Allocation concealment (selection bias) Unclear risk Comment: not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: not described
Incomplete outcome data (attrition bias)
Anthropometrics, Fitness High risk Comment: large quantity of missing data; reasons not provided
Incomplete outcome data (attrition bias)
Physical activity and sedentary time High risk Comment: large quantity of missing data; reasons not provided
Selective reporting (reporting bias) Unclear risk Comment: protocol not published
Cluster RCT ‐ Recruitment bias High risk Comment: schools recruited and randomised 8 months before baseline measurements
Cluster RCT ‐ Baseline imbalance Unclear risk Comment: adjusted for BMI; many others not considered (e.g. only half of participants had data on socioeconomic status)
Cluster RCT ‐ Loss of clusters Unclear risk Comment: not described
Cluster RCT ‐ Incorrect analysis Low risk Comment: clustering accounted for in analysis