Healthy Living Anson Study (HLA)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Hypertension; Cancer; Heart Disease; Diabetes Type 2; High Cholesterol; Obesity (Disorder)

Treatments: Behavioral: Physical Activity Comparator; Behavioral: Nutrition Education and Food Delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07126587

OT2HL158287 (U.S. NIH Grant/Contract)

24-2854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Nutrition Education and Food Delivery, Then Physical Activity Comparator

Experimental group

Description:

Participants first receive nutrition counseling from a Community Health Advocate (CHA) and 10 biweekly healthy prepared meals for the first four weeks. For the next four weeks, participants will reduce to 6 biweekly healthy prepared meals and 2 produce boxes. After a 6 week break at midpoint, participants will receive peer supported physical activity counseling by a Community Health Advocate (CHA) and a mHealth text messaging for 8 weeks.

Treatment:

Behavioral: Nutrition Education and Food Delivery

Behavioral: Physical Activity Comparator

Physical Activity Comparator, Then Nutrition Education and Food Delivery

Experimental group

Description:

Participants first receive peer supported physical activity counseling by a Community Health Advocate (CHA) and a mHealth text messaging for 8 weeks. After a 6 week break at midpoint, participants will receive nutrition counseling by a Community Health Advocate (CHA) and 10 biweekly healthy prepared meals for the first four weeks. For the next four weeks, participants will reduce to 6 biweekly healthy prepared meals and 2 produce boxes.

Treatment:

Behavioral: Nutrition Education and Food Delivery

Behavioral: Physical Activity Comparator