Blood Pressure Clinical Trial
— ISAOfficial title:
Osage Community Supported Agriculture
Verified date | March 2024 |
Source | Oklahoma State University Center for Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Osage Nation | Pawhuska | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma State University Center for Health Sciences | Osage Nation, University of Oklahoma |
United States,
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) |
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