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

(FAME-H 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: AIDS, Pregnancy, Cancer, 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

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

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.

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 3 4 5}

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 4 5 6 7}

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. ^{4 5 7 8 9}

Who Is on the Research Team?

Seth A Berkowitz, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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

English speaking

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

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 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

What Are the Treatments Tested in This Trial?

Interventions

• MTM + ILI
• Standard MTM

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.

How Is the Trial Designed?

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.

MTM + ILI is already approved in United States for the following indications:

Approved in United States as Medically Tailored Meals and Intensive Lifestyle Intervention for:

• HIV
• Type 2 Diabetes Mellitus
• Food Insecurity

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

A study involving 63 HIV-infected adults showed that a locally made ready-to-use therapeutic food (RUTF) was highly acceptable, with 95% participation, and led to significant weight gain and improved physical activity over three months.

After three months, 73.3% of participants gained weight, with average increases of 3.0 kg in weight and 25.4 mm in mid-upper-arm circumference, indicating the RUTF's effectiveness in addressing malnutrition in this population.

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]

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]

The 6-month individualized diet and physical activity intervention for 28 participants with HIV significantly reduced key diabetes risk factors, including glucose levels (up to 17.6% reduction) and insulin levels (up to 31.4% reduction).

Participants found the intervention acceptable, but concerns about potential stigma related to weight loss and HIV status affected participation and goal achievement, highlighting the need for tailored approaches to address these barriers.

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]

Medical nutrition therapy (MNT) has been shown to effectively improve glycemic control and help maintain a healthy weight in individuals with type 2 diabetes, as demonstrated in two case studies.

The combination of a personalized diet and coaching support from certified experts can significantly reduce cardiovascular risk factors, highlighting the importance of tailored nutrition programs in diabetes management.

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]

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 HIV-Care-Program, which included nutrition and lifestyle counseling over 6 months, significantly reduced the decline in CD4 counts in HIV-infected patients compared to usual care, with a drop of only 46.3 cells in the intervention group versus 129 cells in the control group.

The program also delayed the initiation of antiretroviral therapy (ARV) by about 1 month longer in the intervention group, suggesting it can help manage healthcare resources more effectively while improving patient health outcomes.

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]

Optimizing nutritional status through individualized medical nutrition therapy and education is crucial for the health care of people living with HIV, as it supports their overall health and treatment outcomes.

Despite advancements in HIV treatment leading to longer survival rates, challenges such as food insecurity and nutrition-related complications remain significant, highlighting the need for registered dietitians to play an integral role in managing these issues.

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]

A 14-week group intervention was developed to improve both body image satisfaction and dietary habits specifically for gay and bisexual men living with HIV/AIDS, addressing their unique health challenges.

Improving body image is crucial as it can positively influence dietary habits, which are essential for maintaining a strong immune system in individuals with HIV and AIDS.

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]

Citations

1. 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]

2. 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]

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. 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]

7. 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]

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]