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

Daly 2016.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria: suburb primary schools in Canberra, where the average household income approximates the mean for Australian city dwellers
School exclusion criteria:
Student inclusion criteria: all Grade 2 children in good health, able to participate freely in PE, willing to undertake a series of venous blood collections
Student exclusion criteria:
Setting: school 
Age group: children/adolescents
Gender distribution: females and males
Country/Countries where trial was performed: Australia
Interventions Intervention: specialist PE teacher to replace general classroom teacher programme. An all‐inclusive, enjoyable, challenging yet non‐threatening environment for PA that encouraged students to discover answers to a range of physical movement problems and game strategies themselves, through experimentation and self‐discovery. Lesson plans included game play, fitness activities, skill practice, and core movements
Comparator: continued with usual PE programme (traditional fitness and stretching exercise, including running and walking around the oval) conducted by the generalist classroom teachers, none of whom were formally trained in PE. Teachers rarely participated in activities
Duration of intervention: 4 years
Duration of follow‐up: 4 years
Number of schools: 29
Theoretical framework: —
Outcomes PA duration 
Sedentary time
Study registration ACTRN12612000027819
Publication details Language of publication: English
Funding: other funding (charitable trust)
Publication status: peer‐reviewed journal 
Stated aim for study "The primary aim of the Lifestyle of Our Kids project is to investigate relationships of (a) PA in general, and (b) an externally provided specialist PE program in schools, with physiological and psychological health and development in young children. This study is intended to provide a range of integrated scientific evidence upon which conclusions may be drawn in regard to optimising childhood health and development"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from publication: "after acceptance, the allocation of schools to the intervention or control groups was determined randomly, 2 members of the research team drawing from a shuffled set of 29 envelopes, each of which contained a school name"
Allocation concealment (selection bias) Low risk Comment: allocation concealed until after enrolment
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: participants not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: research staff blinded to group only for some measures
Incomplete outcome data (attrition bias)
Physical activity and sedentary time Low risk Comment: large loss to follow‐up but unrelated to intervention (i.e. relocation)
Selective reporting (reporting bias) High risk Comment: academic performance and hand‐eye coordination not reported
Cluster RCT ‐ Recruitment bias Low risk Comment: students enrolled after randomisation
Cluster RCT ‐ Baseline imbalance Low risk Comment: no baseline imbalance
Cluster RCT ‐ Loss of clusters Low risk Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis Low risk Quote from publication: "school, year, and subject were included in the model as random effects to account for the sample design and hence possible dependence structure in the data"