Delta GREENS Food is Medicine Intervention

Tufts University

Status

Enrolling

Conditions

Cardiometabolic Risk Factors

High Blood Pressure

Diabetes

Obesity

Nutrition Security

Treatments

Other: Food is Medicine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06358859

STUDY00004203

1R01MD018208-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. 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 Growing a Resilient, Enriching, Equitable, Nourishing food System (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.

Full description

Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. 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 Growing a Resilient, Enriching, Equitable, Nourishing food System (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 displays ongoing health disparities rooted in historical racial inequality and 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.

Enrollment

300 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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