ISA: Indigenous Supported Agriculture "Go Healthy"

Sponsor

Oklahoma State University Center for Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05773833

Collaborator

Washington State University (Other), University of Oklahoma (Other), Osage Nation (Other)

400

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy Blood Pressure Overweight or Obesity Food Insecurity Health Status	Behavioral: "Go Healthy" program	N/A

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:

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;
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
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

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Osage Community Supported Agriculture

Actual Study Start Date :

Feb 22, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Go Healthy" Intervention Group "Go Healthy" program	Behavioral: "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
No Intervention: Wait-list Control Group Monetary compensation equal in value to the "Go Healthy" program

Arm

Intervention/Treatment

Experimental: "Go Healthy" Intervention Group

"Go Healthy" program

Behavioral: "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

No Intervention: Wait-list Control Group

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

Outcome Measures

Primary Outcome Measures

Diet using Healthy Eating Index scores [Measured at baseline and immediately post-intervention (16 weeks)]
Change in vegetable and fruit intake using the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24) 2022. This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI score will constitute our primary outcome.
Blood pressure (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in systolic and diastolic blood pressure
HDL (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in HDL levels measured in mg/dL
LDL (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in LDL levels measured in mg/dL
Total cholesterol (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in total cholesterol levels measured in mg/dL
Glucose (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in glucose levels measured in mg/dL
Triglycerides (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in triglyceride levels measured in mg/dL

Secondary Outcome Measures

BMI status using CDC guidelines [Measured at baseline and immediately post-intervention (16 weeks)]
Change in BMI will be calculated by dividing weight in kilograms by height in meters squared. Using CDC guidelines, adults will be categorized into the following groups based 1) underweight (BMI < 18.5); 2) healthy weight (BMI = 18.5-24.9); 3) overweight (BMI = 25.0-29.9); 4) obese (BMI = 30.0-39.9), and 5) morbidly obese (BMI ≥ 40.0). Child BMI will be calculated as a continuous variable using the CDC Child and Teen BMI Calculator.
HbA1c (adults only) [Measured at baseline and immediately post-intervention (16 weeks)]
Change in HbA1c levels
Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module [Measured at baseline and immediately post-intervention (16 weeks)]
Change in food insecurity using the Household Food Security Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members. To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative. Consistent with USDA guidelines, 0-2 affirmatives indicate food security, and 3 or more affirmatives indicate food insecurity.
Overall health status using the Short Form-36 [Measured at baseline and immediately post-intervention (16 weeks)]
Change in overall health status with answer options of excellent, very good, good, fair, or poor using the Short Form-36.
Skin Carotenoids [Measured at baseline and immediately post-intervention (16 weeks)]
Change in skin carotenoid score using the Veggie Meter instrument (scale ranging from 0 to 800). Higher scores indicate better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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