Indigenous Supported Agriculture "Go Healthy" (ISA)

Oklahoma State University Center for Health Sciences

Status: Completed

Conditions: Overweight or Obesity; Health Status; Food Insecurity; Diet, Healthy; Blood Pressure

Treatments: Behavioral: "Go Healthy" program

Study type: Interventional

Funder types: Other

Identifiers

NCT05773833

2021026

Details and patient eligibility

About

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.

Full 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

Enrollment: 580 patients

Sex: All

Ages: 3 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adult Participant Inclusion Criteria:

• 18-75 years of age
• Identify as Native American (index adult participant only)
• Reside in Osage Nation
• Plan to stay in Osage Nation in the next year
• Overweight ot obesity, defined as BMI >= 25 kg/m2, measured by research staff (index adult participant only)
• Willing and able to follow study procedures

Child Participant Inclusion Criteria:

• 3-17 years of age
• Reside in Osage Nation
• Plan to stay in Osage Nation in the next year
• Willing and able to follow study procedures

Exclusion Criteria:

• Those that are pregnant or planning to become pregnant during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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580 participants in 2 patient groups

"Go Healthy" Intervention Group

Experimental group

Description:

"Go Healthy" program

Treatment:

Behavioral: "Go Healthy" program

Wait-list Control Group

No Intervention group

Description:

Monetary compensation equal in value to the "Go Healthy" program