Medically Tailored Meals for Diabetes

Enrolling by invitation at 1 trial location

Overseen By Kate R Sebastian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Dementia, Heart failure, Cirrhosis, Cancer, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the impact of home-delivered, medically tailored meals on individuals with type 2 diabetes. The goal is to determine if these meals can aid in diabetes control, mental health, and healthcare use. Participants are divided into three groups: one receives warm meals delivered several times a week, another receives all meals frozen once a week, and a third group initially does not receive meals. Individuals with type 2 diabetes, a hemoglobin A1c of 7.5% or higher, residing in Austin, and able to store and heat meals at home may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diabetes management and overall health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that medically tailored meals (MTM) are generally safe and well-tolerated. These meals are specifically designed to meet the dietary needs of individuals with certain health conditions, such as diabetes.

For the "Daily Warm" MTM delivered in person, studies suggest benefits, though detailed information on any negative effects is not available. This delivery method includes some human interaction, which may benefit mental health.

For the "Weekly Frozen" MTM delivered by drop shipment, evidence indicates these meals can help reduce overall medical costs, suggesting they are a safe choice for managing health conditions like diabetes. While specific details on side effects are not provided, their cost-effectiveness suggests they are generally beneficial.

Overall, both delivery methods of MTM have shown promise in supporting health without significant safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about medically tailored meals (MTM) for diabetes because these meals offer a personalized approach to managing the condition, which is different from standard dietary advice typically given to patients. The "Daily Warm" MTM delivery provides not only nutritionally optimized meals but also human interaction through in-person delivery, which can enhance patient engagement and adherence. Meanwhile, the "Weekly Frozen" MTM option offers convenience with bulk, no-contact delivery, catering to those who prefer minimal disruptions. Both approaches aim to improve dietary adherence and potentially lead to better blood sugar management, offering a practical alternative to traditional diabetes care methods.

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

Research has shown that specially prepared meals can help manage diabetes by providing nutritious food tailored to health needs. In this trial, participants may receive the "Daily Warm" meal delivery, where meals arrive in person, ensuring regular, healthy meals and offering opportunities for social interaction, which can boost mental health. Alternatively, participants may receive the "Weekly Frozen" meal delivery, which focuses on convenience by providing meals that meet dietary needs without frequent deliveries. Both options in this trial aim to help control diabetes by offering balanced meals specifically designed for diabetes care. ^{2 4 6 7 8}

Who Is on the Research Team?

Maninder K Kahlon, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for older adults aged 55-90 living with type 2 diabetes in Austin, who have a Hemoglobin A1c level of at least 7.5%. Participants must live within the MOWCTX daily delivery route, pass a background check, and have access to a freezer and microwave. Those with dementia, heart failure, cirrhosis, active cancer or receiving hospice care cannot join.

Inclusion Criteria

Your hemoglobin A1c level is 7.5% or higher.

I am available to receive meals during the specified delivery times.

Living in Austin city limits and within a MOWCTX daily delivery route

Exclusion Criteria

Does not pass a MOWCTX background check

I have dementia, heart failure, cirrhosis, or active cancer.

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive their assigned method of meal delivery (weekly frozen or daily warm) for 6 months, including educational materials on healthy eating for diabetes.

6 months

3-5 visits per week for daily warm delivery, 1 visit per week for weekly frozen delivery

Phase 2 Treatment

All arms receive 2-4 meals a week delivered via traditional meal services from MOWCTX, including one hot meal plus a snack delivered daily.

6 months

2-4 visits per week

Follow-up

Participants are monitored for changes in Hemoglobin A1C, mental health, and other outcomes.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Medically tailored meals

Trial Overview The study compares three ways of delivering medically-tailored meals (MTM) to seniors with diabetes: standard Meals on Wheels Central Texas (MOWCTX) delivery with interaction, daily delivery with interaction, and weekly delivery without interaction. There's also a waitlist group. The impact on diabetes control and mental health will be measured.

How Is the Trial Designed?

Group I: Waitlisted control Experimental Treatment 2 Interventions

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * No meal delivery Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week

Group II: "Weekly Frozen" MTM drop shipment Experimental Treatment 2 Interventions

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) delivered once a week * Each week all meals are frozen. * Meals are shipped to the participant's home with no human interaction Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week.

Group III: "Daily Warm" MTM in-person delivery Experimental Treatment 2 Interventions

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) per week, delivered 3-5x per week Mon-Fri * Each delivery day, 1 hot and 1 frozen + snack delivered to the participant's home by trained volunteers and/or paid delivery drivers who provide human interaction. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week. Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Meals on Wheels Central Texas

Collaborator

Trials

3

Recruited

1,700+

Published Research Related to This Trial

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]

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]

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]

In a study of 77 patients with type 2 diabetes over 12 months, a diabetic meal delivery system significantly reduced HbA1c levels from 8.2% to 7.4%, demonstrating its effectiveness in improving glycemic control.

The diabetic meal delivery system was found to be as effective as individual dietary counseling, suggesting it can be a viable option for diabetes management and education in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention with delivery of diabetic meals improves glycemic control in patients with type 2 diabetes mellitus. Imai, S., Kozai, H., Matsuda, M., et al.[2022]

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]

The review discusses the nutrient composition of both standard and specialized enteral formulas designed for patients with diabetes mellitus, highlighting their tailored nutritional needs.

It also evaluates the medical efficacy of these specialized formulas in correcting clinical and metabolic disorders associated with diabetes, suggesting their potential benefits in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methodology of use of an enteral nutrition formulas in diet therapy of patients with type 2 diabetes]. Sharafetdinov, KhKh., Meshcheriakova, VA., Plotnikova, OA.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04277117

Meals for Me: Drop Shipment Versus Personally-delivered ... Experimental : "Daily Warm" MTM in-person delivery. Phase 1 (6 months, months 1-6):. Educational materials on healthy eating for diabetes; 10 medically-tailored ...

2. withpower.com withpower.com/trial/phase-3-2022-6128a

Medically Tailored Meals for Diabetes · Info for Participants What data supports the effectiveness of the treatment Medically Tailored Meals for Diabetes ... Group III: "Daily Warm" MTM in-person deliveryExperimental ...

3. openhand.org openhand.org/about-us/food-is-medicine

Food Is Medicine - San Francisco Project Open Hand services assist those with AIDS/HIV as well as critical illnesses such as heart disease and diabetes. We also provide daily warm, nutritious ...

4. episcopalhealth.org episcopalhealth.org/wp-content/uploads/2022/06/ILOS-exploration_all-sessions.pdf

In lieu of Services Technical Assistance Qualitative results suggest benefits of Daily Warm meal delivery model, but relative benefits and cost/benefit not yet clear. Older. Adult. Focus. Health ...

5. guidestar.org guidestar.org/profile/94-3023551

Project Open Hand - GuideStar Profile Project Open Hand services assist those with AIDS/HIV as well as critical illnesses such as heart disease and diabetes. We also provide daily warm, nutritious ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04277117

Drop Shipment Versus Personally-delivered Meals for Diabetes ... Phase 1 (first 6 months) The intervention arms will receive their assigned method of meal delivery (weekly frozen or daily warm), for a total of 10 meals a week ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/17/NCT04277117/Prot_SAP_001.pdf

FORM: IRB Proposal - Standard Submission Cover page added ... Assess the impact of medically-tailored meals program on diabetes management ... • Arm 2: “Daily Warm” MTM in-person delivery o ... For additional information ...

8. tfosdewsreport.org tfosdewsreport.org/public/images/TFOS_DEWS_II_Management_ther.pdf

TFOS DEWS II Management and Therapy Report treatment to daily warm compress therapy [459]. The group undergoing LipiFlow. ® treatment showed a significant improve- ment in symptoms, meibomian gland ...