Delta GREENS Food is Medicine Intervention

Delta GREENS Mississippi Food is Medicine Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Diabetes; High Blood Pressure; Cardiometabolic Risk Factors; Nutrition Security
• Intervention / Treatment: Other: Food is Medicine

Detailed Description

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. In fact, about 77% of Mississippi counties meet the U.S. Department of Agriculture's definition of food deserts. 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. Food is medicine programs -- health clinic mobile markets, produce prescription programs, and produce delivery - hold significant promise for addressing the alarming crisis of nutrition-related diseases. Across the U.S., Food is Medicine programs are in their infancy and accelerating at a rapid pace; since 2019, USDA has funded 116 produce prescription grants. However, no studies have evaluated the impact of food is medicine programs in a rigorous, randomized controlled trial measuring objective cardiometabolic risk factors among minority populations in communities with persistent disadvantage. 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. This study is focused on Delta GREENS Food is Medicine (FIM) Project. Delta GREENS Food is Medicine 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. Participants will be patients at Delta Health Center (DHC) clinics in Mississippi. The project capitalizes on the past success of community-based efforts and decades of community-engaged research at Tufts University, including prior nutrition work in the Delta region. Despite its unique cultural and agricultural background, the Mississippi Delta has experienced persistent health challenges intertwined with poverty. By collaborating and building upon previous successes, the Delta GREENS FIM Project aims to address these challenges, and become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group.	Other: Food is Medicine; Regularly distributed fruit and vegetable produce boxes and nutrition education materials.
No Intervention: Control; The control group will receive produce boxes later, after they complete study activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in BMI	Change in body mass index (BMI) in intervention group compared to control group	12 month study period for each participant
Change in LDL cholesterol	Change in LDL cholesterol levels in intervention group compared to the control group	12 month study period for each participant
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
Change in blood pressure	Change in blood pressure in intervention group compared to the control group	12 month study period for each participant
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
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
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
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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Tougaloo College, Mississippi; Delta Health Center, Mississippi; Reuben V. Anderson Center
• Investigators: Principal Investigator: Christina D Economos, PhD, Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; High blood pressure; Cardiometabolic risk factors; Food is Medicine; Nutrition-related diseases
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hypertension; Diabetes Mellitus
• Other Study ID Numbers: STUDY00004203; 1R01MD018208-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No