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

Belton 2019.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria: (a) schools have a qualified PE teacher on staff, (b) first year students attending the school were time tabled for a minimum of 70 minutes of PE weekly, (c) schools were mixed gender and were situated in the greater area of a large Irish city
School exclusion criteria:
Student inclusion criteria: first year post primary students (12 to 13 years old) attending post primary education within a particular Irish geographical region
Student exclusion criteria:
Setting: school
Age group: adolescent
Gender distribution: females and males
Country/Countries where trial was performed: Ireland
Interventions Intervention: a whole‐school multi‐component intervention programme, aimed at reducing the age‐related decline of MVPA among adolescents. Key features include
1. PE component: PE teachers received 4 hours of Y‐PATH professional development including 6 targeted lesson plans focusing heavily on motivational climate, integrating health‐related activity core knowledge through fun and engaging practical lessons, with an emphasis on functional movement skill proficiency. Resource cards were used to prompt teachers to enable them to integrate a health‐related activity and fundamental movement skill focus within other core PE content areas. Students were given a PA journal to learn to track PA behaviours and identify ways to increase PA levels, and a PA directory containing information and contact details for local youth sport and PA clubs
2. Whole‐school teacher component: PA promotion workshops for teachers, and development and implementation of a school 'charter' for PA. Teachers were encouraged to be 'active role models'
3. Parent component: information evening for parents and information leaflets distributed through the school newsletter to highlight key strategies for promoting PA beyond the school environment
Comparator: usual care, consisting of regular delivery of the Irish Junior Cycle PE curriculum, and the broader school curricula
Duration of intervention: 2 years
Duration of follow‐up: 2 years
Number of schools: 20
Theoretical framework: social‐ecological framework, self‐determination theory
Outcomes PA duration
Study registration ISRCTN20495704
Publication details Language of publication: English
Funding: Dublin Local Sports Partnerships, Dublin City University Career Start grant
Publication status: peer‐reviewed journal
Stated aim for study "to investigate the effect of participation in the Y‐PATH intervention over a two‐year period on objectively measured MVPA levels of young people"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote from publication: "one school from each pair was then randomly allocated by the study principal investigator to the control group (and the other to the intervention group) using a manual number generator in blocks of 1:1, prior to the commencement of baseline testing"
Allocation concealment (selection bias) High risk Quote from publication: "one school from each pair was then randomly allocated by the study principal investigator to the control group (and the other to the intervention group) using a manual number generator in blocks of 1:1, prior to the commencement of baseline testing"
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote from publication: "not possible given the nature of the intervention"
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote from publication: "not possible given the nature of the intervention"
Incomplete outcome data (attrition bias)
Anthropometrics, Fitness High risk Comment: BMI data missing > 10%
Incomplete outcome data (attrition bias)
Physical activity and sedentary time High risk Comment: Large % missing data
Selective reporting (reporting bias) High risk Comment: BMI data not reported, stated in methods; secondary outcomes listed in clinical trials registry not reported
Cluster RCT ‐ Recruitment bias High risk Comment: baseline data collected after randomisation of schools
Cluster RCT ‐ Baseline imbalance Low risk Comment: groups balanced at baseline [author communication]
Cluster RCT ‐ Loss of clusters High risk Comment: 50% of clusters lost at 24 months
Cluster RCT ‐ Incorrect analysis Low risk Quote from publication: "a three level multilevel structure was proposed with random intercepts, where time (Level one), pupils (Level two) and schools (Level three) served as the grouping variables, where time was treated as a fixed effect in the model but was also incorporated as a random slope effect (repeated measure) in the residual component"