Delta GREENS Food is Medicine Intervention

NCT06358859 | Active Not Recruiting

• 2 other identifiers: STUDY000042031R01MD018208-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Cardiometabolic Risk Factors; High Blood Pressure; Obesity; Nutrition Security

Keywords

Food is Medicine; Diabetes; High blood pressure; Cardiometabolic risk factors; Nutrition-related diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in cardiometabolic risk factor composite score

  12 month study period for each participant

• Change in BMI

  12 month study period for each participant

• Change in LDL cholesterol

  12 month study period for each participant

• Change in non-HDL cholesterol

  12 month study period for each participant

• Change in blood pressure

  12 month study period for each participant

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group.

Other: Food is Medicine

Control

NO INTERVENTION

The control group will receive produce boxes later, after they complete study activities.

Interventions

Food is Medicine OTHER

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

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at participating Delta Health Center (DHC) clinics
• BMI: ≥ 25
• Hemoglobin A1C (HbA1c): \>5.7 to 8.5%, inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Tougaloo College, Mississippi: collaborator
• Delta Health Center, Mississippi: collaborator
• Reuben V. Anderson Center: collaborator

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina D Economos, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Professor, New Balance Chair in Childhood Nutrition Friedman School of Nutrition Science and Policy Tufts University

Model Details: The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 11, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-09

Locations

US (1)