Design and Methods of a Participatory Healthy Eating Intervention for Indigenous Children: The FRESH Study.

ObjectiveTo increase vegetable and fruit intake, reduce body mass index (BMI), and improve parental blood pressure among American Indian families.DesignRandomized, wait-list controlled trial testing a multi-level (environmental, community, family, and individual) multi-component intervention with data collection at baseline and 6 months post-intervention.SettingTribally owned and operated Early Childhood Education (ECE) programs in the Osage Nation in Oklahoma.ParticipantsAmerican Indian families (at least one adult and one child in a ECE program). A sample size of 168 per group will provide power to detect differences in fruit and vegetable intake.InterventionThe 6-month intervention consisted of a (1) ECE-based nutrition and gardening curriculum; (2) nutrition education and food sovereignty curriculum for adults; and (3) ECE program menu modifications.Main outcome measuresThe primary outcome is increase in fruit and vegetable intake, assessed with a 24-h recall for adults and plate weight assessments for children. Secondary outcomes included objective measures of BMI among adults and children and blood pressure among adults.