AUTHOR=Blue Bird Jernigan Valarie , Taniguchi Tori , Haslam Alyson , Williams Mary B. , Maudrie Tara L. , Nikolaus Cassandra J. , Wetherill Marianna S. , Jacob Tvli , Love Charlotte V. , Sisson Susan 

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

JOURNAL=Frontiers in Public Health

VOLUME=Volume 10 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.790008

DOI=10.3389/fpubh.2022.790008

ISSN=2296-2565

ABSTRACT=Objective: To increase vegetable and fruit intake, reduce body mass index (BMI), and improve parental blood pressure among American Indian families. 
Design: Randomized, 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.
Setting: Tribally owned and operated Early Childhood Education (ECE) programs in the Osage Nation reservation in Oklahoma.
Participants: American 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. 
Intervention: The 6-month intervention consisted of a 1) ECE-based nutrition and gardening curriculum; nutrition education and food sovereignty curriculum for adults; and 3) ECE program menu modifications. 
Main Outcome Measures: The primary outcome is increase in fruit and vegetable intake, assessed with a 24-hour 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.
Clinical Trials Unique Identifier: NCT03251950 (https://clinicaltrials.gov/ct2/show/NCT03251950)