Obesity Clinical Trial
Official title:
Delta GREENS Mississippi Food is Medicine Intervention
Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and ~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Patient at participating Delta Health Center (DHC) clinics - BMI: = 25 - Hemoglobin A1C (HbA1c): >5.7 to 8.5%, inclusive Exclusion Criteria: - Type 1 diabetes - Current use of incretin agonists (e.g., semaglutide, dulaglutide, liraglutide) - Uncontrolled hypertension: - Systolic blood pressure > 160 mmHg - Diastolic blood pressure > 100 mmHg - Severe symptomatic cardiovascular disease - Recent (6 months) history of: - Myocardial infarction - Percutaneous coronary intervention - Coronary artery bypass graft - Cerebrovascular disease - Participant in diabetes, nutrition, or weight intervention research in the last 12 months - Another family member or household member is a study participant - History of bariatric surgery or considering bariatric surgery in the next year or prior bariatric surgery - Lack of safe, stable residence and ability to store produce - Lack of telephone - Pregnancy/breastfeeding or intended pregnancy in the next year - Drug or alcohol misuse that would impair the ability to complete study activities - Known psychosis or major psychiatric illness that prevents participation in study activities - Any other reason that in the investigators' best judgment places the participants at risk or increases likelihood of poor adherence |
Country | Name | City | State |
---|---|---|---|
United States | Tufts University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University | Delta Health Center, Mississippi, National Institute on Minority Health and Health Disparities (NIMHD), Reuben V. Anderson Center for Justice at Tougaloo, Tougaloo College, Mississippi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in hemoglobin A1c (HbA1c) | Change in HbA1c in the intervention group compared to the control group | 12 month study period for each participant | |
Secondary | Change in cardiometabolic risk factor composite score | Change in cardiometabolic risk factor composite score which is computed using LDL and non-HDL cholesterol, blood pressure and HbA1c measures), in the intervention group compared to the control group. | 12 month study period for each participant | |
Secondary | Change in BMI | Change in body mass index (BMI) in intervention group compared to control group | 12 month study period for each participant | |
Secondary | Change in LDL cholesterol | Change in LDL cholesterol levels in intervention group compared to the control group | 12 month study period for each participant | |
Secondary | Change in non-HDL cholesterol | Change in non-HDL cholesterol levels in intervention group compared to the control group | 12 month study period for each participant | |
Secondary | Change in blood pressure | Change in blood pressure in intervention group compared to the control group | 12 month study period for each participant | |
Secondary | Change in nutrition security, assessed via a survey | Change in nutrition security in intervention group compared to the control group. This outcome measure will be assessed via a survey. | 12 month study period for each participant | |
Secondary | Change in dietary intake of fruits and vegetables, assessed via a survey | Change in dietary intake of fruits and vegetables in intervention group compared to the control group. This outcome measure will be assessed via a survey. | 12 month study period for each participant | |
Secondary | Change in health care utilization, assessed via review of Electronic Health Records (EHR) | Change in health care utilization, including instances of hospitalization and emergency room visit, in intervention group compared to the control group. This outcome measure will be assessed via review of Electronic Health Records (EHR). | 12 month study period for each participant | |
Secondary | Change in food insecurity, assessed via a survey | Change in food insecurity in the intervention group compared to the control group. This outcome measure will be assessed via a survey. | 12 month study period for each participant |
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