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Clinical Trials/NCT06358859
NCT06358859
Active, not recruiting
Not Applicable

Delta GREENS Mississippi Food is Medicine Intervention

Tufts University1 site in 1 country300 target enrollmentStarted: June 5, 2024Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
Change in hemoglobin A1c (HbA1c)

Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

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

Intervention: Food is Medicine (Other)

Control

No Intervention

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

Outcomes

Primary Outcomes

Change in hemoglobin A1c (HbA1c)

Time Frame: 12 month study period for each participant

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

Secondary Outcomes

  • Change in cardiometabolic risk factor composite score(12 month study period for each participant)
  • Change in LDL cholesterol(12 month study period for each participant)
  • Change in food insecurity, assessed via a survey(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)
  • Change in dietary intake of fruits and vegetables, assessed via a survey(12 month study period for each participant)
  • Change in nutrition security, assessed via a survey(12 month study period for each participant)
  • Change in BMI(12 month study period for each participant)
  • Change in health care utilization, assessed via review of Electronic Health Records (EHR)(12 month study period for each participant)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christina Economos

Dean, Professor, New Balance Chair in Childhood Nutrition Friedman School of Nutrition Science and Policy Tufts University

Tufts University

Study Sites (1)

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