Trevino 2004.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: elementary schools with no previous exposure to Bienestar School exclusion criteria: alternative schools Student inclusion criteria: all Grade 4 children regardless of race and ethnicity Student exclusion criteria: those older than 12 years, students previously diagnosed with type 1 or type 2 diabetes mellitus, and students with extreme dietary values Setting: school, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention: Bienestar Health Progam, 50 sessions of health programming across 7 months to transmit to children 3 health behaviour messages associated with diabetes mellitus control (decreased dietary saturated fat intake, increased dietary fibre intake, increased PA). Taught and reinforced through classroom, home, school cafeteria, and after school care educational activities. PE teachers, parents, school cafeteria staff, and after school care staff were asked to encourage less dietary saturated fat, greater fibre intake, and more PA, to have less saturated fat and more fibre and PA available. Children were asked to set goals aimed at accomplishing targeted behaviours and to keep records of their accomplishments. Children were also asked to encourage their peers and adult caretakers to practise 3 health behaviours. Children and parents who practised the 3 health behaviours were rewarded with coupons from a store set up at school. Students could purchase merchandise with the coupons Comparator: — Duration of intervention: 7 months Duration of follow‐up: 7 months Number of schools: 44 Theoretical framework: social cognitive theory and socioecological theory |
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| Outcomes | Fitness | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (National Institutes of Health ‐ National Institue of Diabetes and Digestive and Kidney Disease) Publication status: peer‐reviewed journal |
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| Stated aim for study | "This study tested the efficacy of the Bienestar Health Program ('well‐being' in Spanish)" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: randomisation took place via a random numbers table |
| Allocation concealment (selection bias) | Low risk | Comment: methods ensured that no one could foresee intervention assignment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from publication: “principals of schools were informed and asked not to inform students, parents or school staff of the intervention assignment” (Trevino 2004, p912) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from publication: "temporary staff, separate from programs and masked to the intervention, were hired and trained to collect the data" |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Comment: outcome data complete |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published or trial registry |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: data collected before randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: groups balanced at baseline |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 1 school withdrew after randomisation |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in the analysis |