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 |
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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 |
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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 |
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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" |