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Active, Not Recruiting

NCT Number: NCT06358859

Delta GREENS 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food is Medicine

Other

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

Primary outcomes

  1. 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

  1. Change in cardiometabolic risk factor composite score

    Time frame: 12 month study period for each participant

    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.

  2. Change in BMI

    Time frame: 12 month study period for each participant

    Change in body mass index (BMI) in intervention group compared to control group

  3. Change in LDL cholesterol

    Time frame: 12 month study period for each participant

    Change in LDL cholesterol levels in intervention group compared to the control group

  4. Change in non-HDL cholesterol

    Time frame: 12 month study period for each participant

    Change in non-HDL cholesterol levels in intervention group compared to the control group

  5. Change in blood pressure

    Time frame: 12 month study period for each participant

    Change in blood pressure in intervention group compared to the control group

  6. Change in nutrition security, assessed via a survey

    Time frame: 12 month study period for each participant

    Change in nutrition security in intervention group compared to the control group. This outcome measure will be assessed via a survey.

  7. Change in dietary intake of fruits and vegetables, assessed via a survey

    Time frame: 12 month study period for each participant

    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.

  8. Change in health care utilization, assessed via review of Electronic Health Records (EHR)

    Time frame: 12 month study period for each participant

    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).

  9. Change in food insecurity, assessed via a survey

    Time frame: 12 month study period for each participant

    Change in food insecurity in the intervention group compared to the control group. This outcome measure will be assessed via a survey.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

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

Registry information

Official study title

Delta GREENS Mississippi Food is Medicine Intervention

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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