Stone 2003.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: projected enrolment of at least 15 children in Grade 3, at least 90% of third‐graders were American Indians, retention rates from Grade 3 to 5 over the past 3 years at least 70%, school meals prepared and administered on‐site, existence of facilities for PA programmes and approval of the study by school, community, and tribal authorities School exclusion criteria: — Student inclusion criteria: Grade 3 students Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA
Interventions	Intervention: the intervention programme was implemented during Grades 3 through 5, with 4 components, including food service, skills‐based classroom curricula, family, and 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 × 45‐minute lessons delivered by teachers weekly for 12 weeks during Grades 3 and 4, decreased to 8 weeks in Grade 5. Food service component consisted of 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 consisted of a minimum of 3 × 30‐minute sessions/week of MVPA based on SPARK. Family component included assistance creating a supportive environment with an interactive forum to discuss Pathways and family action packs and family events at schools Comparator: — Duration of intervention: 12 weeks/year × 3 years Duration of follow‐up: 3 years Number of schools: 41 Theoretical framework: social learning theory, incorporating cultural heritage of American Indians
Outcomes	BMI
Study registration	NCT00000545 (retrospectively registered)
Publication details	Language of publication: English Funding: non‐commercial funding (supported by National Heart, Lung, and Blood Institute grants) Publication status: peer‐reviewed journal
Stated aim for study	"The Pathways Study was launched in 1993 as a field trial to test the effectiveness of a multi‐component school‐based program intended to reduce the prevalence of obesity in American‐Indian students by focusing on healthy environments as well as diet and PA"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: stratified randomisation by a central coordinating centre
Allocation concealment (selection bias)	Low risk	Comment: all participants were allocated at a single point in time following recruitment, so at time of recruitment, allocation was not known
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no participants or personnel were blinded to study condition [author communication]
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: outcome assessors were not blinded to study condition [author communication]
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	Low risk	Comment: outcome data complete
Incomplete outcome data (attrition bias) Physical activity and sedentary time	Low risk	Comment: outcome data complete
Selective reporting (reporting bias)	Low risk	Comment: all outcomes identified a priori were reported
Cluster RCT ‐ Recruitment bias	Low risk	Comment: randomisation conducted after individual recruitment
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: baseline comparison found no difference [author communication]
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters were lost to follow‐up [author communication]
Cluster RCT ‐ Incorrect analysis	Low risk	Comment: describe multi‐level model to account for clustering in analysis section (Caballero 2003)