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

210 Participants Needed

Trial Summary

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.

What data supports the idea that Medically Tailored Groceries for Chronic Health Problems is an effective treatment?

The available research shows that Medically Tailored Groceries, as part of Food is Medicine programs, are promising in managing chronic health problems. These programs aim to integrate healthy food into healthcare to improve health outcomes. Although there is limited strong evidence, the research highlights the potential of these programs to improve diet-related health conditions. Compared to other treatments, Medically Tailored Groceries focus on providing healthy food resources, which can help manage chronic diseases and potentially reduce healthcare costs. However, more studies are needed to confirm their effectiveness and cost-efficiency. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Medically Tailored Groceries and Food Resource Coaching for chronic health problems?

Research shows that 'Food is Medicine' programs, like medically tailored meals, can help manage chronic conditions by providing healthy food options and nutrition education. These programs have shown promise in improving health outcomes and reducing healthcare costs, especially for diet-related conditions. ^{1 2 3 4 5}

What safety data exists for Medically Tailored Groceries for chronic health problems?

The available research does not provide specific safety data for Medically Tailored Groceries or similar interventions like Food is Medicine programs. However, these programs are generally considered safe as they focus on providing healthy, medically-appropriate food to manage chronic conditions. The studies highlight the potential benefits of these interventions, such as improved dietary behaviors and health outcomes, but emphasize the need for more research to establish strong evidence of their effectiveness and safety. ^{3 5 6 7 8}

Is it safe to participate in a Medically Tailored Groceries program?

Medically Tailored Groceries programs, which provide healthy food to manage health conditions, are generally considered safe for humans. These programs aim to improve diet and health outcomes, and there is no evidence suggesting they pose safety risks. ^{3 5 6 7 8}

Is the treatment Medically Tailored Groceries and Food Resource Coaching a promising treatment for chronic health problems?

Yes, Medically Tailored Groceries and Food Resource Coaching is a promising treatment. It involves providing healthy food and guidance to help manage chronic health issues. This approach, known as 'Food is Medicine', aims to improve health by integrating nutritious food into healthcare. It has the potential to prevent and manage diseases, especially those related to diet, by making healthy food more accessible and part of medical care. ^{1 2 3 7 9}

How is the Medically Tailored Groceries and Food Resource Coaching treatment different from other treatments for chronic health problems?

This treatment is unique because it involves providing patients with groceries specifically tailored to their medical needs, along with coaching on how to use these foods to manage their health, rather than relying solely on medication. It integrates nutrition directly into healthcare, aiming to address food insecurity and improve dietary habits as part of managing chronic conditions. ^{1 2 3 7 9}

What is the purpose of this trial?

Eating healthy foods can help people manage health problems, like Type 2 diabetes and heart disease. Many people want to eat healthier, but changing eating behaviors is hard. Patients don't always know what foods to eat for their health problems and are hesitant to try foods that may be unfamiliar. These challenges are made more difficult when families have lower incomes, which makes accessing healthy foods difficult and trying new foods riskier when on a budget. Food is Medicine programs connect people to healthy foods that help them manage health problems. One example is a medically tailored grocery program. This program provides a patient with free groceries selected to help their medical condition. For example, a patient receives fruits, vegetables, whole grains, and low-salt, low-sugar foods if they have high blood pressure. Food resource coaching is another strategy for eating healthy food. This approach provides a coach that supports learning healthy eating habits when facing financial challenges by using available food resources. Among other strategies, a coach may teach the participant how to meal plan and shop at nearby stores to increase healthy and delicious eating patterns. In our study, the investigators will ask lower-income patients with at least one chronic health problem at a safety-net clinic if they want to participate in a Food is Medicine program. Patients that want to participate will be randomly placed in one of three groups. One group will get medically tailored groceries from a free food market for four months. Another group will get medically tailored groceries and food resource coaching from a free food market. The last group will get free food from the same market for four months, but food will not be medically tailored, and they will not meet with a coach. Participants will have the option to continue getting food from the market at the end of the study if they want to. This study will help us learn what patients think about Food is Medicine programs and how to best carry out these programs in the future. The study will also help us determine if providing medically tailored groceries and food resource coaching helps patients improve their diet. The investigators will use what is learned in this study to create a larger and longer program that can be provided in safety-net clinics throughout Dallas-Fort Worth. Our main goal is to build a sustainable and helpful program for patients that may not otherwise have access to healthy foods and eating habits that set the foundation for better health.

Research Team

Kelseanna Hollis-Hansen, PhD, MPH

Principal Investigator

UT Southwestern Medical Center

Tammy Leonard, PhD

Principal Investigator

UT Southwestern Medical Center

Jaclyn Albin, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Food Is Medicine: A Presidential Advisory From the American Heart Association. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Health-related Culinary Education: A Summary of Representative Emerging Programs for Health Professionals and Patients. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Retail Nutrition Programs and Outcomes: An Evidence Analysis Center Scoping Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop. [2021]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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