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NCT07126587NARecruitingAccepts Healthy Volunteers

Healthy Living Anson Study

University of North Carolina, Chapel Hill

Start Date

9/24/2025

Completion Date

3/30/2028

Summary

The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve the quality of their diet compared to participants who receive only physical activity education and coaching.

Detailed Description

Purpose: Evaluate whether a Food is Medicine (FIM) intervention improves the quality of food intake among rural adults who have at least one chronic disease or are at risk for chronic disease compared to those receiving a physical activity intervention. Participants: English speaking Anson County residents 18 years or older Procedures: Randomized delayed intervention control study design - 4 months receive either the FIM intervention (healthy frozen meals and/or produce box, and education by a Community Health Advocate (CHA) or physical activity (PA) education and support via a CHA. At the end of the 4 months, the FIM group will receive the PA intervention, and the PA group receives the FIM intervention with both groups continuing for another 4 months. Data collected will include a funder required survey (demographics, social, and behavioral factors) plus additional study related questions and biometrics. The survey will be completed online or in person for those requiring internet access or support. The biometrics will be obtained at an in-person session. Once enrollment is complete, participants will be randomized into either the FIM or PA group and receive their study materials. Data collection will occur at baseline, midpoint, and at the end of the study.

Eligibility Criteria

Age Range: 18 years to 99 years

Inclusion Criteria: * Potential participants must be a resident of Anson County. * At least 18 years of age. * Have or be at risk for a chronic disease. * Ability to make own dietary decisions. * Ability to travel to a central Anson County location for data collection and group class sessions. * Ability and willingness to try the prepared meals. * Ability to store 10 frozen meals in a freezer. * Ability to communicate in English * No dietary restrictions or food allergies such that a Mediterranean diet is not appropriate.

Interventions

BEHAVIORAL

Nutrition Education and Food Delivery

BEHAVIORAL

Physical Activity Comparator

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Conditions

Obesity (Disorder)Diabetes Type 2Heart DiseaseHypertensionCancerHigh Cholesterol

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States