Jago 2019.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: primary schools from South Gloucestershire and North Somerset local authority School exclusion criteria: — Student inclusion criteria: pupils in Year 3 or 4 (aged 7 to 9) at baseline Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country where trial was performed: UK |
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| Interventions |
Intervention: Action 3:30R after‐school clubs, scheduled to run twice per week for 15 weeks and last 60 minutes per session. Sessions were designed to promote maximal participation, skill development, cooperation, problem‐solving, PA, and choice. Sessions began with fun warm‐up activities and moved through a series of small sided games and activities with a focus on fun and participation while improving fundamental movement skills such as running, catching, throwing, and using space in invasion games. Teaching assistants took part in 5 days (25 hours) of training to promote and foster aspects of motivation drawn within the club, with focus on creating a club climate that supported autonomy, relatedness, and competence. Teaching assistants completed a log book to indicate whether sessions were delivered fully, partially, or not at all and a register of attendance Comparator: — Duration of intervention: 15 weeks Duration of follow‐up: 15 weeks Number of schools: 12 Theoretical framework: self‐determination theory |
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| Outcomes | PA duration Sedentary time BMI Health‐related quality of life |
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| Study registration | ISRCTN34001941 | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (governmental organisation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of this study is to test the feasibility of the revised version of Action 3:30 which has been reworked to more successfully appeal to and engage girls and recruit less active children" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "computer generated" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "allocation will be performed (computer‐generated allocation) by an independent member of the Bristol Randomised Trials Collaboration who will be blind to the school identity" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from publication: "randomisation will take place after baseline data collection has been completed. School is the unit of randomisation" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: attempted to blind staff, but unsuccessful [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: low loss to follow‐up at student level |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | Low risk | Comment: low loss to follow‐up at student level |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes in protocol paper reported |
| Cluster RCT ‐ Recruitment bias | Low risk | Quote from publication: "all measures will be taken at baseline prior to randomisation" |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: Control and intervention groups did not differ by demographics, PA, or psychosocial outcomes at baseline |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 2 schools dropped out after randomisation |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "multivariable mixed effects linear regression that took account of the clustering of pupils in schools was conducted" |