Indigenous Supported Agriculture "Go Healthy"

Blood Pressure Clinical Trial

— ISA  

Official title:

Osage Community Supported Agriculture

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05773833
• Other study ID #: 2021026
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 580
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	The Osage Nation	Pawhuska	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	Osage Nation, University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet using Healthy Eating Index scores	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.	Measured at baseline and immediately post-intervention (16 weeks)
Primary	Blood pressure (adults only)	Change in systolic and diastolic blood pressure	Measured at baseline and immediately post-intervention (16 weeks)
Primary	HDL (adults only)	Change in HDL levels measured in mg/dL	Measured at baseline and immediately post-intervention (16 weeks)
Primary	LDL (adults only)	Change in LDL levels measured in mg/dL	Measured at baseline and immediately post-intervention (16 weeks)
Primary	Total cholesterol (adults only)	Change in total cholesterol levels measured in mg/dL	Measured at baseline and immediately post-intervention (16 weeks)
Primary	Glucose (adults only)	Change in glucose levels measured in mg/dL	Measured at baseline and immediately post-intervention (16 weeks)
Primary	Triglycerides (adults only)	Change in triglyceride levels measured in mg/dL	Measured at baseline and immediately post-intervention (16 weeks)
Secondary	BMI status using CDC guidelines	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.	Measured at baseline and immediately post-intervention (16 weeks)
Secondary	HbA1c (adults only)	Change in HbA1c levels	Measured at baseline and immediately post-intervention (16 weeks)
Secondary	Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module	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.	Measured at baseline and immediately post-intervention (16 weeks)
Secondary	Overall health status using the Short Form-36	Change in overall health status with answer options of excellent, very good, good, fair, or poor using the Short Form-36.	Measured at baseline and immediately post-intervention (16 weeks)
Secondary	Skin Carotenoids	Change in skin carotenoid score using the Veggie Meter instrument (scale ranging from 0 to 800). Higher scores indicate better outcome.	Measured at baseline and immediately post-intervention (16 weeks)