Indigenous Supported Agriculture "Go Healthy"

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05773833
Study type	Interventional
Source	Oklahoma State University Center for Health Sciences
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 22, 2023
Completion date	June 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Indigenous Supported Agriculture "Go Healthy" — ISA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms