Obesity (Disorder)HLANCT07126587
Healthy Living Anson Study
A study testing Nutrition Education and Food Delivery and Physical Activity Comparator in people with Obesity (Disorder) and Diabetes Type 2, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (Disorder), Diabetes Type 2, Heart Disease
- What is being tested?
- Nutrition Education and Food Delivery and Physical Activity Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Healthy Living Anson
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.
Read the 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.
- Conditions
- Obesity (Disorder), Diabetes Type 2, Heart Disease, Hypertension, Cancer, High Cholesterol
- Being tested
- Nutrition Education and Food Delivery, Physical Activity Comparator
- Keywords
- Healthy Living Anson, HLA study, nutrition, healthy eating, overweight (BMI ≥ 25)
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Heart Diseases, Hypertension, Neoplasms, Hypercholesterolemia, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education and Food DeliveryBehavioural
Healthy frozen meals, produce boxes, and nutrition counseling
Physical Activity ComparatorBehavioural
Physical activity counseling, mHealth text messaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Nutrition Education and Food Delivery; Behavioral: Physical Activity Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Midpoint (Month 4), Endpoint (up to Month 10)
Secondary outcomes (3)
Physical Activity Questionnaire
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.
Measured: Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)
Skin Carotenoids
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.
Measured: Baseline, Midpoint (month 4), Endpoint (up to month 10)
Nutrition Insecurity
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.
Measured: baseline, endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start24 Sep 2025
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Anissa I Vines, MS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126587
- Sponsor's protocol ID
- 24-2854
- Other IDs
- OT2HL158287
- Acronym
- HLA
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living Anson
- ClinicalTrials.gov ID
- NCT07126587
- Acronym / sponsor ID
- HLA / 24-2854
- Conditions
- Obesity (Disorder), Diabetes Type 2, Heart Disease, Hypertension, Cancer, High Cholesterol
- Keywords
- Healthy Living Anson, HLA study, nutrition, healthy eating, overweight (BMI ≥ 25)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Westat, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education and Food Delivery, Then Physical Activity Comparator | Experimental | Behavioral: 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 Delivery | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Education and Food DeliveryHealthy frozen meals, produce boxes, and nutrition counseling | Behavioural | Nutrition Education and Food Delivery, Then Physical Activity Comparator, Physical Activity Comparator, Then Nutrition Education and Food Delivery |
| Physical Activity ComparatorPhysical activity counseling, mHealth text messaging | Behavioural | Nutrition Education and Food Delivery, Then Physical Activity Comparator, Physical Activity Comparator, Then Nutrition Education and Food Delivery |
Primary outcome
Med-South Dietary Risk Assessment Score
Time frame: 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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa I Vines, MS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education and Food Delivery and Physical Activity Comparator in people with Obesity (Disorder) and Diabetes Type 2, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Med-South Dietary Risk Assessment Score (time frame: Baseline, Midpoint (Month 4), Endpoint (up to Month 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.