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Trials / Completed

CompletedNCT05773833

Indigenous Supported Agriculture "Go Healthy"

Osage Community Supported Agriculture

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
580 (actual)
Sponsor
Oklahoma State University Center for Health Sciences · Academic / Other
Sex
All
Age
3 Years – 75 Years
Healthy volunteers
Accepted

Summary

Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.

Detailed description

The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings. Specific Aims: 1. Conduct a randomized controlled trial to test the newly developed ISA program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity; 2. Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and 3. Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems

Conditions

Interventions

TypeNameDescription
BEHAVIORAL"Go Healthy" programWeekly food boxes of fresh fruits and vegetables for 16 weeks; healthy eating and traditional foods curriculum available inside the box; monthly in-person healthy eating and traditional Indigenous foods cooking workshop; Indigenous cooking demonstration video website links to accompany recipes; and a kitchen starter kit with kitchen cooking supplies

Timeline

Start date
2023-02-22
Primary completion
2024-07-26
Completion
2024-07-26
First posted
2023-03-17
Last updated
2026-03-18
Results posted
2026-03-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05773833. Inclusion in this directory is not an endorsement.