Nutrition Education and Food Delivery for Obesity

(HLA Trial)

Overseen By Anissa I Vines, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether teaching people about healthy eating and providing nutritious meals can improve their diet more effectively than just teaching them about exercise. Participants will either begin with exercise coaching and later receive nutrition education and meals, or they will follow the reverse order. It suits residents of Anson County who can make their own food choices, are at risk for chronic diseases, and can store and try frozen meals. The goal is to determine which approach better improves diet quality. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance dietary interventions for chronic disease prevention.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diet and nutrition, so you may not need to change your medications, but it's best to check with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Healthy Living Anson Study includes teaching about nutrition and providing healthy meals. No reports of negative effects from these activities exist. This study does not test a new drug; it aims to improve diet and exercise habits.

Generally, nutrition advice and receiving healthy meals are safe. These are common lifestyle changes recommended for better health. Participants in this study are likely to benefit from improved eating habits and increased nutrition knowledge. No specific reports of negative effects or safety issues with these activities have been noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Nutrition Education and Food Delivery for obesity because it combines personalized support with practical food solutions, potentially addressing both knowledge and accessibility barriers in current obesity treatments. Traditional obesity treatments often focus on diet plans or exercise programs individually, but this approach integrates both, offering a comprehensive lifestyle change. By providing peer-supported counseling and ready-to-eat healthy meals, this method could make it easier for participants to adopt and maintain healthier habits. The use of biweekly meal deliveries and produce boxes also ensures participants have consistent access to nutritious food, which is a unique feature not typically included in standard obesity care.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that education and healthy meal programs can improve diet quality and help with obesity. Studies have found that when people receive nutrition advice and healthy prepared meals, they tend to eat better, often leading to weight loss and better health. In the Healthy Living Anson Study, participants will be divided into two groups to evaluate these methods. One group will first receive physical activity counseling followed by nutrition education and food delivery, while the other group will start with nutrition education and food delivery before transitioning to physical activity counseling. By focusing on both teaching about nutrition and providing easy access to healthy meals, participants are more likely to maintain positive changes. These programs highlight the importance of regular, healthy eating to reach weight management goals. ^{1 6 7 8 9}

Who Is on the Research Team?

Anissa I Vines, MS, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like obesity, type 2 diabetes, high cholesterol, cardiovascular disease, and hypertension. Participants should be interested in improving their diet or increasing physical activity.

Inclusion Criteria

Ability to communicate in English

Potential participants must be a resident of Anson County

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive either the FIM intervention or physical activity education for 4 months

16 weeks

Baseline, Midpoint, and Endpoint visits

Crossover Intervention

Participants switch interventions and continue for another 4 months

16 weeks

Midpoint and Endpoint visits

Follow-up

Participants are monitored for dietary and physical activity outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Living Anson Study

Trial Overview The study tests if providing education on nutrition along with healthy meals can improve diet quality compared to just receiving physical activity guidance and coaching.

How Is the Trial Designed?

Group I: Physical Activity Comparator, Then Nutrition Education and Food Delivery Experimental Treatment 2 Interventions

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.

Group II: Nutrition Education and Food Delivery, Then Physical Activity Comparator Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07126587

NCT07126587 | Healthy Living Anson Study The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39246719/

Incidence of new onset type 2 diabetes in adults living with ... Tirzepatide is associated with significantly reduced risk of developing T2D and major adverse cardiovascular events in individuals living with obesity and T2D ...

3. icer.org icer.org/wp-content/uploads/2025/09/ICER_Obesity_Draft-Report_For-Publication_090925.pdf

Semaglutide and Tirzepatide for Obesity: Effectiveness and ... tirzepatide and quality of life in adults with obesity: Results from the SURMOUNT-1 study. Diabetes, obesity & metabolism. 2025-01-01 2025 ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16364

Real‐world evidence on the utilization, clinical and ... Real-world studies demonstrate high discontinuation rates of GLP-1RAs (20%–50%) within the first year, and the use of much lower doses than those evaluated in ...

5. bmj.com bmj.com/content/344/bmj.e3732

Effectiveness of home based early intervention on ... The home based early intervention delivered by trained community nurses was effective in reducing mean BMI for children at age 2.

6. vbn.aau.dk vbn.aau.dk/ws/portalfiles/portal/742473643/Anson_et_al._2024_._Incidence_of_new_onset_type_2_diabetes_in_adults_living_with_obesity_treated_with_tirzepatide_or_semaglutide_-_real_world_evidence_from_an_international_retrospective_cohort_study.pdf

Incidence of new onset type 2 diabetes in adults living with ... In summary, from our real-world data study, compared to Semaglutide, Tirzepatide is associated with significantly reduced risk of developing T2D and major.

7. app.trialscreen.org app.trialscreen.org/trials/healthy-living-anson-trial-nct07126587

Healthy Living Anson Study Participants may experience improved diet quality, better nutrition knowledge, increased physical activity, potential health improvements from chronic disease ...

8. digitalcommons.gardner-webb.edu digitalcommons.gardner-webb.edu/cgi/viewcontent.cgi?article=1030&context=nursing-dnp

DNP Project Active Anson Outcome data suggests that the gamification intervention encouraged participants to adopt the walking challenge and integrate and track physical activity within ...

9. researchgate.net researchgate.net/scientific-contributions/Matthew-Anson-2233654505

Matthew Anson's research works | University of Manchester ... We aimed to compare the estimate of the relative effect of tirzepatide, semaglutide, and liraglutide in reducing the risk of major adverse liver outcomes (MALOs) ...