Healthy Living Anson Study

NCT07126587 | Recruiting

• 2 other identifiers: 24-2854OT2HL158287
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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; High Cholesterol

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Med-South Dietary Risk Assessment Score

  The Med-South Dietary Risk Assessment (DRA) is scored as the sum of the column score for each numbered item, with column score multiplied by 0.5 for Items 3.3 and 3.4. The score ranges from 0 to 10, 0 meaning no adherence and 10 meaning full adherence. With regard to diet quality, the first response option is considered "desirable," the second "could be improved," and the third "needs to be improved.

  Baseline, Midpoint (Month 4), Endpoint (up to Month 10)

Secondary Outcomes (3)

• Physical Activity Questionnaire

  Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)

• Skin Carotenoids

  Baseline, Midpoint (month 4), Endpoint (up to month 10)

• Nutrition Insecurity

  baseline, endpoint

Study Arms (2)

Nutrition Education and Food Delivery, Then Physical Activity Comparator

EXPERIMENTAL

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.

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

Physical Activity Comparator, Then Nutrition Education and Food Delivery

EXPERIMENTAL

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.

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

Interventions

Nutrition Education and Food Delivery BEHAVIORAL

Healthy frozen meals, produce boxes, and nutrition counseling

Nutrition Education and Food Delivery, Then Physical Activity Comparator; Physical Activity Comparator, Then Nutrition Education and Food Delivery

Physical Activity Comparator BEHAVIORAL

Physical activity counseling, mHealth text messaging

Nutrition Education and Food Delivery, Then Physical Activity Comparator; Physical Activity Comparator, Then Nutrition Education and Food Delivery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Westat: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Heart Diseases; Hypertension; Neoplasms; Hypercholesterolemia; Overweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Anissa I Vines, MS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anissa I Vines, MS, PhD

CONTACT

19198431210; avines@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized delayed intervention control study - 4 months participants receive either the FIM intervention (healthy frozen meals, produce box, and education by a community health advocate (CHA)) or a physical activity (PA) education and support via a CHA. At the end of the 4 months, the FIM group will receive maintenance and the PA component, and the PA group receives the FIM component and continue for another 4 months.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)