Food is Medicine program in the Mississippi Delta
Delta GREENS Mississippi Food is Medicine Intervention
This study is testing a program that provides healthy food to people in the Mississippi Delta to see if it helps improve conditions like diabetes, high blood pressure, and obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06358859 on ClinicalTrials.gov |
What this trial studies
This project aims to address cardiometabolic risk factors such as diabetes, high blood pressure, and obesity in the Mississippi Delta through a Food is Medicine intervention. The initiative focuses on Bolivar, Washington, and Sunflower counties, which are designated health disparity populations with high rates of food insecurity and nutrition-related diseases. Participants will receive regular access to healthy food options as part of a comprehensive program designed to improve health outcomes. The study will rigorously evaluate the impact of this intervention on objective cardiometabolic risk factors among minority populations.
Who should consider this trial
Good fit: Ideal candidates include individuals with a BMI of 25 or higher and an HbA1c level between 5.7% and 8.5% who are patients at participating Delta Health Center clinics.
Not a fit: Patients with type 1 diabetes, uncontrolled hypertension, or severe cardiovascular disease may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly improve health outcomes for individuals suffering from nutrition-related diseases in underserved communities.
How similar studies have performed: While Food is Medicine programs are emerging across the U.S., this study is novel as it rigorously evaluates their impact in a randomized controlled trial specifically targeting minority populations in disadvantaged communities.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Tufts University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina D Economos, PhD — Tufts University
- Study coordinator: Daniel Schultz, MS, RDN, LD
- Email: daniel.schultz@tufts.edu
- Phone: 262-627-0155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.