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