Clinical trial NCT05773833: Indigenous Supported Agriculture "Go Healthy"
Official title: Osage Community Supported Agriculture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Blood Pressure
Overweight or Obesity
Food Insecurity
Health Status
Keywords: Blood Pressure
Obesity
CBPR
American Indian
BMI
Food Environment
Blood Lipids
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
name: Osage Nation
First posted: 2023-03-17
Enrollment: 580
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Diet using Healthy Eating Index scores
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Blood pressure (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: HDL (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: LDL (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Total cholesterol (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Glucose (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Triglycerides (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
Secondary outcomes:
measure: BMI status using CDC guidelines
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: HbA1c (adults only)
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Overall health status using the Short Form-36
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
measure: Skin Carotenoids
timeFrame: Measured at baseline and immediately post-intervention (16 weeks)
Other outcomes:
Locations:
city: Pawhuska
country: United States
facility: The Osage Nation
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Valarie Jernigan, DrPH
role: PRINCIPAL_INVESTIGATOR
References: