Clinical trial

Delta GREENS Food is Medicine Intervention

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06358859

Active, not recruitingNot applicableInterventional

What this study is about

Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. 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 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionCardiometabolic Risk Factors, Diabetes, High Blood Pressure, Obesity, Nutrition Security

Full registry criteria

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

Treatments and study arms

Food is Medicine

Other

Regularly distributed fruit and vegetable produce boxes and nutrition education materials.

Primary outcomes

Change in hemoglobin A1c (HbA1c)12 month study period for each participant

Change in HbA1c in the intervention group compared to the control group

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tufts University🇺🇸 Boston, Massachusetts, United States