Indigenous Supported Agriculture "Go Healthy"

NCT05773833 | Completed Results

• 1 other identifier: 2021026
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Blood Pressure; Obesity; CBPR; American Indian; BMI; Food Environment; Blood Lipids

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in BMI From Baseline

  Baseline and 16-week follow-up

• Change in HbA1c From Baseline

  Baseline and 16-week follow-up

• Change in Food Insecurity From Baseline

  Baseline and 16-week follow-up

• Change in Skin Carotenoids From Baseline

  Baseline and 16-week follow-up

• Change in Health Status From Baseline to Follow-up

  Baseline to 16-week follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Households that received the "Go Healthy" program

Behavioral: "Go Healthy" program

Wait-list Control Group

NO INTERVENTION

Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over

Interventions

"Go Healthy" program 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

Intervention Group

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead
• University of Oklahoma: collaborator
• Osage Nation: collaborator

Study Sites (1)

The Osage Nation

Pawhuska, Oklahoma, 74056, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kaylee Clyma
• Organization: Oklahoma State University Center for Health Sciences

kaylee.clyma@okstate.edu

918-561-1581

Study Officials

• Valarie Jernigan, DrPH

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 17, 2023
• Study Start: February 22, 2023
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)