Stone 2003.
| Methods | Design: cluster randomized controlled trial Theoretical framework: Social Learning Theory, incorporating Cultural Heritage of American‐Indians Number of intervention groups: 1 Number of control groups: 1 Follow‐up: immediately post‐intervention | |
| Participants | Intervention: 644 Control: 653 Age: grade 3 (mean age not provided) Sex: male and female Ethnicity: American‐Indian |
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| Interventions | Country: US Setting: school, unstated if urban or rural Provider: teacher, nutritionist (for nutritional support) Duration: 3 years (12 weeks per year) Intervention: the intervention program was implemented during third through fifth grades, with 4 components including: food service, skills‐based classroom curricula, family, and physical education (PE). The intervention combined Social Learning Theory and principles of American Indian culture and practices with indigenous learning modes (e.g. story telling) incorporated. Classroom component: 2 x 45‐min lessons delivered by teachers weekly for 12 weeks during grades 3 and 4, decreased to 8 weeks in grade 5. Food service component: nutrient guidelines and tools for reducing fat content of school meals while meeting nutrient requirements. Food service staff provided skill‐building for planning, purchasing, and preparing lower‐fat school meals. PE component: a minimum of 3 x 30‐min sessions per week of moderate to vigorous physical activity based on SPARK. Family component: assistance creating a supportive environment with an interactive forum to discuss Pathways and additionally, 1) family action packs, and 2) family events at schools Control: not specified | |
| Outcomes | Duration of physical activity Body mass index (kg/m2) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: randomization process not reported |
| Allocation concealment (selection bias) | Low risk | Comment: criterion not applicable because all participants were allocated at 1 point in time following recruitment, so at time of recruitment allocation was not known |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information given, likely not done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome data complete |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported |
| Confounders controlled? | Low risk | Comment: all relevant confounders were accounted for |
| Data collection methods valid and reliable? | Low risk | Comment: data collection tools shown to be valid and reliable |