Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes

(FAME-H Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Seth A Berkowitz, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Glucocorticoids

Disqualifiers: AIDS, Pregnancy, Cancer, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.

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 are using medications that affect blood sugar intermittently, you may not be eligible to participate.

What data supports the effectiveness of the treatment Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes?

Research shows that medically tailored meals (MTM) can improve health outcomes for people with type 2 diabetes by providing nutritious meals that help manage the condition and reduce healthcare costs. Additionally, personalized nutrition and coaching have been effective in improving diabetes management, suggesting that combining MTM with lifestyle interventions could be beneficial for individuals with both HIV and type 2 diabetes. ^{1 2 3 4 5}

Is the Medically Tailored Meals and Lifestyle Intervention safe for humans?

Medically Tailored Meals (MTM) programs, which provide pre-prepared meals and nutrition education, are generally considered safe and are used to help manage chronic conditions like type 2 diabetes and HIV. These programs aim to improve health by ensuring access to nutritious food, and there is no indication of safety concerns in the available research. ^{1 2 6 7 8}

How is the Medically Tailored Meals and Intensive Lifestyle Intervention treatment unique for HIV and Type 2 Diabetes?

This treatment is unique because it combines medically tailored meals, which are pre-prepared and nutritionally appropriate for managing chronic conditions, with an intensive lifestyle intervention that includes nutrition education. This approach not only addresses the dietary needs of patients but also supports them in making sustainable lifestyle changes, which is particularly beneficial for those with limited access to nutritious food. ^{1 2 4 7 9}

Research Team

Seth A Berkowitz, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

Adults over 18, who speak English and are not planning to move for a year, can join this trial if they're food insecure with HIV and Type 2 Diabetes or at high risk of it. They must be able to control their diet and consent to all study activities. Pregnant individuals, those in similar studies recently, with certain illnesses or drug misuse cannot participate.

Inclusion Criteria

No plans to move from the area for at least 1 year

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

I am 18 years old or older.

Exclusion Criteria

Pregnancy/breastfeeding or intended pregnancy in the next year

You have participated in a study about diabetes, nutrition, or weight in the past year.

Lack of telephone

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals and intensive lifestyle intervention or standard nutrition education for 12 months

12 months

Weekly home meal delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• MTM + ILI (Behavioral Intervention)
• Standard MTM (Behavioral Intervention)

Trial Overview The trial is testing whether specially prepared meals plus an intensive lifestyle program (MTM + ILI) help adults with HIV and diabetes better than the usual medical treatment for diabetes alone. Participants will be randomly assigned to one of these two groups.

Participant Groups

Group I: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) Experimental Treatment 1 Intervention

The Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-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: Standard MTM Active Control 1 Intervention

The Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of North Carolina at Chapel Hill Chapel Hill, NC

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1588

Patients Recruited

4,364,000+

Community Servings

Collaborator

Trials

4

Patients Recruited

510+

Community Servings

Collaborator

Trials

4

Patients Recruited

510+

Massachusetts General Hospital

Collaborator

Trials

3066

Patients Recruited

13,430,000+

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

Collaborator

Trials

2513

Patients Recruited

4,366,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and effectiveness of chickpea sesame-based ready-to-use therapeutic food in malnourished HIV-positive adults. Bahwere, P., Sadler, K., Collins, S.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing risk of Type 2 diabetes in HIV: a mixed-methods investigation of the STOP-Diabetes diet and physical activity intervention. Duncan, AD., Peters, BS., Rivas, C., et al.[2021]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. Unverdorben, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an HIV-Care-Program on immunological parameters in HIV-positive patients in Yaoundé, Cameroon: a cluster-randomized trial. Nkengfack, GN., Torimiro, JN., Ngogang, J., 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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: Nutrition Intervention and Human Immunodeficiency Virus Infection. Fields-Gardner, C., Campa, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A group intervention to improve body image satisfaction and dietary habits in gay and bisexual men living with HIV/AIDS. Feldman, MB., Torino, JA., Swift, M.[2017]

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. New Zealand pubmed.ncbi.nlm.nih.gov

Acceptability and effectiveness of chickpea sesame-based ready-to-use therapeutic food in malnourished HIV-positive adults. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Reducing risk of Type 2 diabetes in HIV: a mixed-methods investigation of the STOP-Diabetes diet and physical activity intervention. [2021]

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

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

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

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of an HIV-Care-Program on immunological parameters in HIV-positive patients in Yaoundé, Cameroon: a cluster-randomized trial. [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

Position of the American Dietetic Association: Nutrition Intervention and Human Immunodeficiency Virus Infection. [2019]

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

A group intervention to improve body image satisfaction and dietary habits in gay and bisexual men living with HIV/AIDS. [2017]