Medically Tailored Meals for Type 2 Diabetes

(FAME-D Trial)

Overseen By Katharine Ricks, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Glucocorticoids

Disqualifiers: Pregnancy, Advanced kidney disease, Psychosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether specially prepared meals can assist people with Type 2 Diabetes who struggle with food access. Participants will either receive weekly home-delivered meals or continue their usual diabetes care with a small monthly food stipend. The goal is to determine if these tailored meals, part of the Food As Medicine program, can enhance diabetes management for those experiencing food insecurity. This trial suits individuals with Type 2 Diabetes who have difficulty affording sufficient food and controlling their diet. As an unphased trial, it provides a unique opportunity to explore innovative solutions for managing diabetes while addressing food insecurity.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you intermittently use medications like glucocorticoids that affect blood sugar, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you use medications like glucocorticoids that affect blood sugar, you might not be eligible to participate.

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

Research has shown that medically tailored meals (MTM) are safe and beneficial for health. These meals can improve health outcomes, particularly for individuals with serious illnesses or special dietary needs. For instance, one study found that MTM programs improved blood sugar levels and reduced hospital visits. Another study examined the effects over five years and suggested that MTM could shorten hospital stays and reduce healthcare costs.

These meals are specifically designed to meet each person's medical and dietary needs. Studies have not reported any major safety issues with MTMs, indicating that people generally tolerate them well. Overall, evidence suggests that MTM is a safe way to enhance health, especially for those with conditions like diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using medically tailored meals (MTMs) for managing Type 2 diabetes because, unlike traditional treatments that often rely on medications like metformin or insulin, this approach uses food as a direct form of medicine. MTMs involve delivering meals specifically designed to meet the medical and nutritional needs of individuals with diabetes, along with a lifestyle intervention program to promote long-term healthy habits. This method not only provides a new way to manage blood sugar levels but also empowers individuals with the skills to sustain these benefits beyond the meal delivery period. The potential for MTMs to improve outcomes by integrating nutrition and lifestyle changes makes this a promising and holistic approach to diabetes care.

What evidence suggests that medically tailored meals could be an effective treatment for Type 2 Diabetes?

Research has shown that medically tailored meals (MTMs) can benefit people with type 2 diabetes. These meals have been linked to significant improvements in blood sugar levels, specifically hemoglobin A1c (HbA1c), which is crucial for diabetes management. Lowering HbA1c can help prevent long-term health problems related to diabetes. In this trial, participants in the MTM arm will receive weekly home meal deliveries and a lifestyle intervention program. Studies also show that MTMs can improve access to healthy food and reduce stress related to managing diabetes. These benefits suggest that MTMs might be a promising option for managing diabetes, especially for those who have difficulty accessing enough healthy food. ^{2 5 6 7 8}

Who Is on the Research Team?

Seth Berkowitz, MD

Principal Investigator

UNC

Are You a Good Fit for This Trial?

This trial is for adults with food insecurity and Type 2 Diabetes Mellitus who speak English, plan to stay in the area for a year, have specific levels of Hemoglobin A1c and BMI, can control their diet, consent to participate, and aren't planning pregnancy. Excluded are those with severe psychiatric issues or substance misuse, involved in similar research recently, without stable housing or phone access, certain medical conditions including advanced kidney disease or recent cancer (except some localized cases).

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Willing and able to provide written informed consent and participate in all study activities

Your average blood sugar level (Hemoglobin A1c) is between 7.0% and 12.0% in the past year.

Exclusion Criteria

Known psychosis or major psychiatric illness that prevents participation with study activities

Another family member or household member is a study participant. Only one member of each household may take part in this study.

I have had cancer other than non-melanoma skin cancer, but it was cured or has been in remission for over 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals (MTM) with weekly delivery and a telephone-based lifestyle intervention for 6 months

6 months

Follow-up

Participants are monitored for diabetes self-care activities and other health outcomes after the treatment period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Food As Medicine

Trial Overview The study compares two approaches: one group receives medically tailored meals (MTM) plus lifestyle calls for six months; the other gets usual diabetes care plus a monthly food subsidy. The MTM includes weekly delivery of ready-to-eat meals covering half of weekly intake.

How Is the Trial Designed?

Group I: Medically Tailored Meal (MTM) Experimental Treatment 1 Intervention

The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.

Group II: Food Subsidy Active Control 1 Intervention

As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.

Food As Medicine is already approved in United States for the following indications:

Approved in United States as Medically Tailored Meals (MTM) for:

• Type 2 Diabetes Mellitus (T2DM)

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Community Servings

Collaborator

Trials

4

Recruited

510+

Community Servings

Collaborator

Trials

4

Recruited

510+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Implementing national coverage for medically tailored meals (MTMs) could potentially prevent approximately 1.6 million hospitalizations and save $13.6 billion in health care costs annually for patients with diet-related diseases.

Over a 10-year period, MTM coverage could lead to an estimated 18.3 million averted hospitalizations and $484.5 billion in reduced health care expenditures, highlighting the significant cost-effectiveness of this intervention for patients with chronic diet-sensitive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. Hager, K., Cudhea, FP., Wong, JB., et al.[2023]

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.

However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. Boxer, R., Drace, ML., Kelly, C., et al.[2023]

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]

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]

Medically tailored meals (MTMs) have been shown to effectively improve health outcomes for food-insecure patients with type 2 diabetes, highlighting the importance of nutrition in diabetes management.

Improving access to nutritious food through MTMs not only benefits patient health but also has the potential to reduce overall healthcare costs, suggesting a need for further research to support insurance coverage for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. Rabaut, LJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453110/

Assessing the impact of medically tailored meals and ... Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored ...

2. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839527/

Medically Tailored Meals for Food Insecurity and Type 2 ... To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, ...

4. link.springer.com link.springer.com/article/10.1007/s11606-024-09248-x

Impact of Medically Tailored Meals on Clinical Outcomes ... Data collected on 72% of those getting the intervention showed significant improvements in food security, as well as reduced diabetes distress, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04828785

NCT04828785 | Food As MedicinE for Diabetes Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12120087/

Impact of Medically Tailored Meals on Clinical Outcomes ... The control group received usual care. Outcomes were change from baseline to 6 months in A1c (primary), body mass index (BMI), blood pressure, ...

7. 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.

8. healthbegins.org healthbegins.org/wp-content/uploads/2024/10/Medically-Tailored-Meals-Evidence-Assessment.pdf

Evidence Assessment Library - Medically Tailored Meals Summary: There is sufficient evidence that medically tailored meals (MTM) can have positive impacts on health and social outcomes, and that for ...