Indigenous Supported Agriculture "Go Healthy"

NCT ID: NCT05773833

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-07-26

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Go Healthy" Intervention Group

"Go Healthy" program

Group Type: EXPERIMENTAL

"Go Healthy" program

Intervention Type: BEHAVIORAL

Weekly 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

Wait-list Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"Go Healthy" program

Weekly 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: collaborator

Osage Nation

UNKNOWN

Sponsor Role: collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valarie Jernigan, DrPH

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

The Osage Nation

Pawhuska, Oklahoma, United States

Countries

United States

Other Identifiers

2021026

Identifier Type: -

Identifier Source: org_study_id