Jago 2011.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: student body at least 50% minority (African American, Hispanic or Latino, and/or American Indian) and/or greater than 50% eligible for free or reduced lunch; annual student attrition from all causes is ≤ 25%; expected cohort size at end of study is at least 50 per school; school authorities willing to accept randomisation, permit grade‐wide data collection, and assist with mass mailings to students' homes; possess Federal Wide Assurance to conduct research and agree to adhere to the protocol; schools must also have at least 1 play area that satisfied intervention requirements School exclusion criteria: — Student inclusion criteria: enrolled in Grade 6 in fall 2006, able to participate in school’s standard PE programme, not previously diagnosed with diabetes, providing parent's or guardian’s informed consent and minor child informed assent to participate in data collection and evaluation procedures Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention: intervention had 4 integrated components. The first component was change in the total school food environment. The second component was a programme of peer‐led, teacher‐facilitated learning activities. The third component was a social marketing campaign that had a different theme for each semester of the intervention. The fourth element was a revised, more active PE curriculum. Schools also received around $10,000 of equipment and a teacher assistant to facilitate small‐group activities that were intended to increase activity time during sessions Comparator: control group activities were limited to recruitment and data collection only Duration of intervention: 2.5 years Duration of follow‐up: 2.5 years Number of schools: 42 Theoretical framework: developmental learning frameworks |
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| Outcomes | Fitness BMI |
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| Study registration | NCT00458029 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal |
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| Stated aim for study | "HEALTHY was a primary prevention trial with a public health objective of preventing the development of risk factors for type 2 diabetes in adolescents" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: coordinating centre developed randomisation scheme |
| Allocation concealment (selection bias) | Low risk | Comment: randomisation occurred at a coordinating centre |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: study took measures to mask intervention to both students and parents |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: separate study staff not aware of treatment assignment administered data collection protocols |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: loss to follow‐up similar between groups; most often due to transfer to another school |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported on |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: students enrolled after randomisation, but investigators attempted to mask students and parents to school assignment |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: baseline balance; models adjusted for confounders |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: analyses accounted for clustered design |