Healthy Living Anson Study

NCT07126587 — Not applicable, Completed, 44 participants, University of North Carolina, Chapel Hill

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Healthy Living Anson

RegistryNCT07126587, acronym HLA
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, prevention
Enrollment44 (Actual)
SponsorUniversity of North Carolina, Chapel Hill (Other); collaborators: Westat, National Heart, Lung, and Blood Institute (NHLBI)
ConditionsObesity (Disorder), Diabetes Type 2, Heart Disease, Hypertension, Cancer, High Cholesterol
InterventionsNutrition Education and Food Delivery, Physical Activity Comparator (Behavioral)
Datesstart 2025-09-24, primary completion 2026-08-28, completion 2026-08-28, first posted 2025-08-17, last updated 2026-09-28
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity (Disorder) All trials for Diabetes Type 2 All trials of Nutrition Education and Food Delivery All trials of Physical Activity Comparator

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Nutrition Education and Food Delivery, Then Physical Activity ComparatorExperimentalBehavioral: Nutrition Education and Food Delivery; Behavioral: Physical Activity ComparatorParticipants 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.
Physical Activity Comparator, Then Nutrition Education and Food DeliveryExperimentalBehavioral: Nutrition Education and Food Delivery; Behavioral: Physical Activity ComparatorParticipants 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.
  • Nutrition Education and Food Delivery (Behavioral): Healthy frozen meals, produce boxes, and nutrition counseling
  • Physical Activity Comparator (Behavioral): Physical activity counseling, mHealth text messaging

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Physical Activity Questionnaire [Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)]: Assessed by the International Physical Activity Questionnaire (IPAQ) - Short Form. This questionnaire is a well-validated 7-day physical activity recall assessment for physical activity. This will measure frequency (days per week) and duration (time per day) for each specific type of activity. Three specific activity types will be scored, walking, moderate-intensity activity, and vigorous-intensity activity. Participants will be scored based on metabolic equivalent of task units (MET, energy expenditure). This will be determined by multiplying the frequency by duration (in hours). Each activity type will have MET calculated separately, and the summation of each score will generate the the overall physical activity score in MET units. Scores will range from 0-99. We will only report the overall score. Higher scores indicate higher levels of physical activity and more energy expenditure.
  • Skin Carotenoids [Baseline, Midpoint (month 4), Endpoint (up to month 10)]: Description: Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. A Veggie Meter uses reflection spectroscopy to determine the level of skin carotenoids using the fingertip. Measurements are taken three times, with scores being averaged and reported. A higher score indicates more fruit and vegetable intake.
  • Nutrition Insecurity [baseline, endpoint]: Nutrition Insecurity will be measured using a survey with one item. This item indicates the frequency in which a participant has skipped or cut the size of meals due to lack of finances. Frequency is established using a likert scale, always to never, with one selection option. Always would signify high nutrition insecurity, and never would signify low nutrition insecurity.

+Eligibility

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
University of North Carolina at Chapel HillChapel Hill, North CarolinaUnited States

+Study documents

+Investigators

+Funding

NIH grants: OT2HL158287