Indigenous Supported Agriculture "Go Healthy" (ISA)

Osage Community Supported Agriculture

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Food Insecurity; Overweight or Obesity; Diet, Healthy; Health Status
• Intervention / Treatment: Behavioral: "Go Healthy" program

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

• Study Type: Interventional
• Enrollment (Actual): 580
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Pawhuska, Oklahoma, United States, 74056
      • The Osage Nation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Households that received the "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; Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diet From Baseline	Measued on adults only. Change in vegetable and fruit intake using the National Cancer Instititute's Automated Self-Administered 24-hour Recall (ASA-24). 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 scores are reported.	Baseline to 16-week follow-up
Change in Systolic Blood Pressure From Baseline	Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.	Baseline and 16-week follow-up
Change in Diastolic Blood Pressure From Baseline	Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.	Baseline and 16-week follow-up
Change in LDL-C From Baseline	Measured on adults only. Used a non-fasting blood sample device	Baseline and 16-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI From Baseline	BMI (kg/m2) was calculated using measuredvheight and weight	Baseline and 16-week follow-up
Change in HbA1c From Baseline	Measured on adults only. Used a non-fasting blood sample device	Baseline and 16-week follow-up
Change in Food Insecurity From Baseline	Assessed on adults only. Scale: U.S. Household Food Security Survey Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply. 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. Total score range: 0-18. The lower scores, the greater improvement in food security.	Baseline and 16-week follow-up
Change in Skin Carotenoids From Baseline	Skin carotenoids were quantified using the Veggie Meter. Score range: 0 to 800. The higher the score, the higher vegetable intake.	Baseline and 16-week follow-up
Change in Health Status From Baseline to Follow-up	Health status was measured using one question from the 36-Item Short Form Health Survey questionnaire "In general, how would you rate your health status?" With response options of Excellent, Very Good, Good, Fair, and Poor. This outcome assesses proportion difference between baseline and follow-up of excellent/very good.	Baseline to 16-week follow-up

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Collaborators: University of Oklahoma; Osage Nation
• Investigators: Principal Investigator: Valarie Jernigan, DrPH, Oklahoma State University Center for Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Blood Pressure; BMI; American Indian; CBPR; Blood Lipids; Food Environment
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 2021026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No