N/A
N=562
Indigenous Supported Agriculture "Go Healthy"
Diet, Healthy · Blood Pressure · Overweight or Obesity · Food Insecurity · Health Status
Bottom Line
View on ClinicalTrials.gov: NCT05773833 ↗Enrolled (actual)
562
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change in Diet From Baseline — 4.1; 0.4 Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- "Go Healthy" program (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Oklahoma State University Center for Health Sciences
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Diet From Baseline |
4.1; 0.4 | — |
| PRIMARY Change in Systolic Blood Pressure From Baseline |
-1.3; -2.9 | — |
| PRIMARY Change in Diastolic Blood Pressure From Baseline |
-0.4; -2.5 | — |
| PRIMARY Change in LDL-C From Baseline |
-0.7; 5.3 | — |
| SECONDARY Change in BMI From Baseline |
-0.01; 0.3; 0.6; 0.6 | — |
| SECONDARY Change in HbA1c From Baseline |
-0.35; 0.02 | — |
| SECONDARY Change in Food Insecurity From Baseline |
-0.84; -0.98 | — |
| SECONDARY Change in Skin Carotenoids From Baseline |
-18.0; -10.5; -34.2; -15.5 | — |
| SECONDARY Change in Health Status From Baseline to Follow-up |
-0.013; -0.007 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05773833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.