Delta GREENS Food is Medicine Intervention (NCT06358859) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Delta GREENS Food is Medicine Intervention
United States300 participantsStarted 2024-06-05
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hemoglobin A1c (HbA1c)
Timeframe: 12 month study period for each participant