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Completed

NCT Number: NCT05773833

Indigenous Supported Agriculture "Go Healthy"

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.

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Key information

Conditions

Diet, Healthy Blood Pressure Body Weight Food Insecurity Health Status Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Osage Nation

Pawhuska, Oklahoma, 74056, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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

Primary outcomes

  1. Change in Diet From Baseline

    Time frame: Baseline to 16-week follow-up

    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.

  2. Change in Systolic Blood Pressure From Baseline

    Time frame: Baseline and 16-week follow-up

    Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.

  3. Change in Diastolic Blood Pressure From Baseline

    Time frame: Baseline and 16-week follow-up

    Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.

  4. Change in LDL-C From Baseline

    Time frame: Baseline and 16-week follow-up

    Measured on adults only. Used a non-fasting blood sample device

Secondary outcomes

  1. Change in BMI From Baseline

    Time frame: Baseline and 16-week follow-up

    BMI (kg/m2) was calculated using measuredvheight and weight

  2. Change in HbA1c From Baseline

    Time frame: Baseline and 16-week follow-up

    Measured on adults only. Used a non-fasting blood sample device

  3. Change in Food Insecurity From Baseline

    Time frame: Baseline and 16-week follow-up

    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.

  4. Change in Skin Carotenoids From Baseline

    Time frame: Baseline and 16-week follow-up

    Skin carotenoids were quantified using the Veggie Meter. Score range: 0 to 800. The higher the score, the higher vegetable intake.

  5. Change in Health Status From Baseline to Follow-up

    Time frame: Baseline to 16-week 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.

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

  • Osage Nation
  • University of Oklahoma

Registry information

Official study title

Osage Community Supported Agriculture

Acronym: ISA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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