Medically Tailored Groceries for Chronic Health Problems

Overseen By Carolyn Program Coordinator, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Eating disorder, Psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how providing free, medically tailored groceries can help manage chronic conditions like Type 2 diabetes, high cholesterol, or high blood pressure. Participants will be divided into three groups: one receiving only the groceries, another receiving groceries plus coaching on healthy eating (referred to as Food Resource Coaching), and the last group receiving non-tailored free groceries. The goal is to determine if these strategies improve eating habits and overall health. To qualify, participants must have one of the mentioned health conditions and face financial challenges. As an unphased trial, this study offers a unique opportunity to access resources that may enhance health and well-being.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on providing healthy foods rather than changing medication use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing healthy foods rather than changing medication use.

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

Research has shown that medically tailored groceries are generally safe for people. These programs offer healthy, carefully selected foods to help manage illnesses like diabetes or heart disease. Previous studies have not identified any major safety issues with these grocery programs. They focus on providing foods like fruits, vegetables, and whole grains, which support overall health.

Additionally, pairing these groceries with food resource coaching remains safe. Coaching helps participants learn to plan meals and shop smartly, making healthy eating easier. No reports of negative effects have emerged from this combination.

Overall, both the groceries and coaching are designed to support health without causing harm. These programs use food as a tool to improve health, and existing evidence suggests they are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using medically tailored groceries for chronic health problems because they offer a personalized approach to nutrition that standard treatments don't. Unlike typical dietary advice or standard food market services, these groceries are specifically designed to meet the unique health needs of individuals, potentially improving health outcomes more effectively. Additionally, the combination of these tailored groceries with food resource coaching provides not only the right foods but also the support and education needed to make lasting dietary changes, setting it apart from other interventions.

What evidence suggests that this trial's treatments could be effective for managing chronic health problems?

Studies have shown that providing specially chosen groceries can improve health for people with long-term illnesses like diabetes and heart disease. These programs offer foods selected by a dietitian to help manage these conditions. Early research suggests they can boost health and lower healthcare costs. In this trial, one group will receive medically tailored groceries and food resource coaching, which includes skills like meal planning and shopping, to potentially enhance these benefits. Another group will receive only medically tailored groceries without coaching. A third group will receive usual free community food market services without tailored food. Together, these methods aim to improve eating habits and health, especially for those who have limited access to healthy foods. ^{1 3 5 6 7}

Who Is on the Research Team?

Jaclyn Albin, MD

Principal Investigator

UT Southwestern Medical Center

Tammy Leonard, PhD

Principal Investigator

UT Southwestern Medical Center

Kelseanna Hollis-Hansen, PhD, MPH

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for lower-income patients with chronic health issues like Type 2 diabetes or high blood pressure, who are treated at a safety-net clinic. Participants should be interested in improving their diet and willing to try new healthy eating habits.

Inclusion Criteria

Income <185% of the federal poverty threshold (self-report)

I can give my consent.

My electronic health records confirm I have Diabetes, Dyslipidemia, or Hypertension.

Exclusion Criteria

Condition or dietary restriction that precludes eating study foods (e.g., liquid diet, eating disorder)

Another member of the household participating

Receipt of services from Crossroads within the past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive medically tailored groceries and/or food resource coaching for 4 months

16 weeks

Regular visits to the food market

Follow-up

Participants are monitored for diet quality and nutrition security after the intervention

8 weeks

Open-label extension (optional)

Participants may continue to receive food from the market after the study ends

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Groceries and Food Resource Coaching

Trial Overview

The study tests if providing medically tailored groceries and food resource coaching can improve diets of patients with chronic conditions. One group receives these tailored groceries and coaching, while the other gets regular free food without specific tailoring or coaching.

How Is the Trial Designed?

Group I: Medically tailored groceries and food resource coaching Experimental Treatment 3 Interventions

Medically tailored groceries and food resource coaching.

Group II: Medically tailored groceries Experimental Treatment 2 Interventions

Medically tailored groceries only, no coaching.

Group III: Usual free community food market services Active Control 1 Intervention

Usual free community food market services, no tailoring of food received.

Medically Tailored Groceries and Food Resource Coaching is already approved in United States for the following indications:

Approved in United States as Medically Tailored Groceries and Food Resource Coaching for:

• Type 2 diabetes
• High blood pressure
• Heart disease
• Chronic health problems

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Parkland Health and Hospital System

Collaborator

Trials

20

Recruited

99,300+

Crossroads Community Services

Collaborator

Trials

1

Recruited

210+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Nutrition plays a crucial role in promoting health and managing diseases, yet it is often overlooked in medical training and practice, leading to under-prescription of healthy eating.

Access to nutritious food is essential for food to be considered medicine; community initiatives and physician involvement are necessary to improve food availability and support healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When food isn't medicine - A challenge for physicians and health systems. Lucan, SC.[2020]

Culinary medicine (CM) programs are emerging to educate both health professionals and patients on healthy food preparation, with 10 identified programs educating 2,654 health professionals and 4,225 patients annually.

Despite the growth of CM programs, there is a lack of consensus on learning objectives and outcomes, highlighting the need for a unified approach to enhance their effectiveness and research on their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related Culinary Education: A Summary of Representative Emerging Programs for Health Professionals and Patients. Polak, R., Phillips, EM., Nordgren, J., et al.[2020]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

A 12-week 'produce prescription' program for 50 adults with type 2 diabetes and food insecurity significantly improved diet quality, with an increase in the Alternate Healthy Eating Index score by 12.9 points, indicating better consumption of fruits, vegetables, and whole grains.

Participants also experienced improvements in blood lipids and weight loss, with 92% completing the study, suggesting high feasibility and satisfaction with the program, warranting further research into its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Feasibility and Dietary Impact of a "Produce Prescription" Program for Adults with Undermanaged Type 2 Diabetes and Food Insecurity in Australia. Wu, JH., Trieu, K., Coyle, D., et al.[2023]

Food as Medicine interventions in food retail settings can effectively improve health outcomes and reduce healthcare costs, particularly when combining incentive programs, personalized nutrition education, and path-to-purchase marketing.

A total of 186 papers and 25 systematic reviews were analyzed, highlighting the importance of registered dietitian nutritionists in developing these interventions to help consumers manage chronic diseases and improve their nutritional choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retail Nutrition Programs and Outcomes: An Evidence Analysis Center Scoping Review. Yoder, AD., Proaño, GV., Handu, D.[2021]

Medical foods are designed to help patients manage specific diseases and enhance their quality of life, but there are significant regulatory and practical challenges in making these products available to patients.

The workshop highlighted the importance of understanding regulatory definitions and clinical guidelines for medical foods, as well as the need for innovation and research to improve access and effectiveness for conditions like epilepsy, diabetes, and inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop. Holmes, JL., Biella, A., Morck, T., et al.[2021]

Unhealthy diets significantly hinder the health of the U.S. population, with many Americans not following recommended dietary guidelines due to barriers like food insecurity and marketing practices.

The 'Food Is Medicine' approach, which provides healthy food resources to manage health conditions, shows promise but lacks strong evidence linking these interventions to improved health outcomes and cost savings, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Is Medicine: A Presidential Advisory From the American Heart Association. Volpp, KG., Berkowitz, SA., Sharma, SV., et al.[2023]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11533393/

Health outcomes reported by healthcare providers and ...

We found evidence that participation in MANNA's MTM program was associated with favorable health outcomes for clients with serious illness and nutritional risk.

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odphp.health.gov/sites/default/files/2024-09/Food%20Is%20Medicine%20Landscape%20Summary%20FINAL%20508.pdf

Food Is Medicine Landscape Summary

Medically tailored groceries programs provide food boxes selected by an RDN to assist individuals with managing diet related illnesses. • Food ...

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WEB_Tufts_2025_FIM Fact Sheet 2_031425

These programs provide medically tailored meals, groceries, and produce to support disease management, in combination with nutrition and culinary education, as ...

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About FIM | Health Care by Food

Preliminary evidence indicates that delivering food is medicine programs may improve health outcomes, reduce health care utilization and costs, address health ...

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Food is Medicine | RF

Initial research shows these programs improve health outcomes for patients with conditions like hypertension, diabetes, and cardiovascular disease. Integrating ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11749760/

Providing medically tailored groceries and food resource ...

MTG consists of minimally prepared foods that might be offered in a pantry setting but are carefully selected to support health goals. In some ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06242808

Medically Tailored Groceries and Food Resource Coaching

Food is Medicine programs connect people to healthy foods that help them manage health problems. One example is a medically tailored grocery program. This ...