Medically Tailored Meals for Diabetes

Recruiting 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

320 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Medically Tailored Meals for Diabetes?

Research shows that medically tailored meals can improve health outcomes for people with type 2 diabetes, especially those who struggle to access nutritious food. These meals have been effective in improving blood sugar control and reducing healthcare costs for food-insecure diabetic patients. ^{1 2 3 4 5}

Are medically tailored meals safe for humans?

The research does not specifically mention any safety concerns related to medically tailored meals, suggesting they are generally safe for humans. ^{1 2 3 4 6}

How are medically tailored meals different from other treatments for diabetes?

Medically tailored meals are unique because they provide home-delivered, nutritionally appropriate food specifically designed for individuals with diabetes, especially those who struggle to access healthy food. Unlike traditional treatments that may focus on medication, these meals aim to improve health by ensuring consistent access to the right nutrition, which can help manage diabetes more effectively and reduce healthcare costs. ^{1 2 3 6 7}

What is the purpose of this trial?

This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use.

Research Team

Maninder K Kahlon, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

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

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

3. 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]

4. Japan pubmed.ncbi.nlm.nih.gov

Intervention with delivery of diabetic meals improves glycemic control in patients with type 2 diabetes mellitus. [2022]

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

A Journey to Improved Inpatient Glycemic Control by Redesigning Meal Delivery and Insulin Administration. [2016]

6. United States 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. [2023]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Methodology of use of an enteral nutrition formulas in diet therapy of patients with type 2 diabetes]. [2017]