Recruiting

Education & Meals

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07126587

Conditions

Obesity (Disorder)

Diabetes Type 2

Heart Disease

Hypertension

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Nutrition Education and Food Delivery

Physical Activity Comparator

Study Details

Brief 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.

Conditions

Obesity (Disorder)

Diabetes Type 2

Heart Disease

Hypertension

Cancer

Study ID

NCT07126587

Start date

Sep 24, 2025

Status verified date

Aug, 2025

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Nutrition Education and Food Delivery, Then Physical Activity Comparator

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.

experimental: Physical Activity Comparator, Then Nutrition Education and Food Delivery

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.

Interventions

Nutrition Education and Food Delivery

Healthy frozen meals, produce boxes, and nutrition counseling

Physical Activity Comparator

Physical activity counseling, mHealth text messaging

Primary outcome measure

  • Med-South Dietary Risk Assessment Score [ Time Frame: Baseline, Midpoint (Month 4), Endpoint (up to Month 10) ]

Central Contacts and Locations

Central contacts

Anissa I Vines, MS, PhD

19198431210avines@email.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Oct 30, 2025

Last verified

Aug, 2025

Keywords

  • Healthy Living Anson
  • HLA study
  • nutrition
  • healthy eating
  • overweight (BMI ≥ 25)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-10-30.