Healthy Living Anson Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition Education and Food Delivery, Physical Activity Comparator.
- Who it may be relevant to
- Registry conditions: Obesity (Disorder), Diabetes Type 2, Heart Disease, Hypertension. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Healthy Living Anson
Overview
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.
Interventions
- Behavioral Nutrition Education and Food Delivery
Healthy frozen meals, produce boxes, and nutrition counseling - Behavioral Physical Activity Comparator
Physical activity counseling, mHealth text messaging
Primary outcome measures
- Med-South Dietary Risk Assessment Score [Time frame: Baseline, Midpoint (Month 4), Endpoint (up to Month 10)]
Secondary outcome measures (3)
- Physical Activity Questionnaire [Time frame: Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)]
- Skin Carotenoids [Time frame: Baseline, Midpoint (month 4), Endpoint (up to month 10)]
- Nutrition Insecurity [Time frame: baseline, endpoint]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07126587 · 24-2854 · OT2HL158287