nctId: NCT06358859 id: STUDY00004203 id: 1R01MD018208-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MD018208-01 briefTitle: Delta GREENS Food is Medicine Intervention overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-11 date: 2024-04-11 name: Tufts University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) name: Tougaloo College, Mississippi name: Delta Health Center, Mississippi name: Reuben V. Anderson Center for Justice at Tougaloo briefSummary: 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. conditions: Cardiometabolic Risk Factors conditions: Diabetes conditions: High Blood Pressure conditions: Obesity conditions: Nutrition Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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. primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Food is Medicine measure: Change in hemoglobin A1c (HbA1c) measure: Change in cardiometabolic risk factor composite score measure: Change in BMI measure: Change in LDL cholesterol measure: Change in non-HDL cholesterol measure: Change in blood pressure measure: Change in nutrition security, assessed via a survey measure: Change in dietary intake of fruits and vegetables, assessed via a survey measure: Change in health care utilization, assessed via review of Electronic Health Records (EHR) measure: Change in food insecurity, assessed via a survey sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University city: Boston state: Massachusetts zip: 02111 country: United States name: Daniel Schultz, MS, RDN, LD role: CONTACT phone: 262-627-0155 email: daniel.schultz@tufts.edu name: Shanti Sharma, PhD role: CONTACT email: shanti.sharma@tufts.edu lat: 42.35843 lon: -71.05977 hasResults: False