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 trial explores how specialized meal plans and lifestyle changes can assist people living with HIV and type 2 diabetes, or those at risk, especially if they face food insecurity. Participants will receive meals tailored to their medical needs and lifestyle coaching over the phone to determine if this combination improves health more than receiving meals alone. This study suits individuals diagnosed with HIV, those with type 2 diabetes or at risk, and those experiencing food insecurity affecting daily life. As an unphased trial, it offers a unique opportunity to contribute to research that could lead to better health strategies for managing HIV and diabetes.

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

Research shows that meals specifically designed for medical needs and focused lifestyle changes are generally safe. Studies have found that providing these meals to patients with diabetes not only improves their diet and access to food but also reduces hospital visits by up to 50%. Using these meals and lifestyle changes together is well-tolerated, with no major side effects reported in past studies. These results provide strong evidence for the safety of this treatment approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medically Tailored Meals (MTM) combined with Intensive Lifestyle Intervention (ILI) for HIV and Type 2 Diabetes because it takes a personalized approach to treatment. Unlike standard care, which often involves medication management and general dietary advice, this treatment provides weekly home-delivered meals specifically tailored to each individual's medical needs. It also includes a comprehensive 20-session telephone lifestyle program, which helps participants build skills and behaviors to sustain health benefits even after the intervention ends. This holistic method not only targets nutrition but also emphasizes long-term lifestyle changes, offering a unique and potentially more effective way to manage these conditions.

What evidence suggests that this trial's treatments could be effective for HIV and Type 2 Diabetes?

Research has shown that specially prepared meals, when combined with a focused lifestyle program, can greatly improve health for people with HIV and Type 2 Diabetes (T2DM). In this trial, participants in one arm will receive Medically Tailored Meals (MTM) combined with an Intensive Lifestyle Intervention (ILI), which includes weekly home meal delivery and a 20-session telephone lifestyle change program. Studies have found that such combined interventions can reduce hospital visits by up to 50% and lower overall healthcare use. One study showed that these meals significantly improved patients' diet quality, increasing their Healthy Eating Index score by 31.4 points. Additionally, providing these meals to diabetic patients improved their diet and food security. These findings suggest that using these meals along with lifestyle changes could effectively manage both HIV and T2DM, especially for those who struggle to get enough food. ^{1 2 3 4 6}

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

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05026723

NCT05026723 | Food as Medicine for HIV and Diabetes The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient- ...

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

Assessing the impact of medically tailored meals and ... Pilot studies of MTM, including services provided by our local meal provider, demonstrated up to 50% fewer hospitalizations, reduced healthcare utilization and ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2812982

Effect of an Intensive Food-as-Medicine Program on Health ... A randomized crossover study found that delivering medically tailored meals to patients with diabetes improved diet and food security, and a ...

4. nejm.org nejm.org/doi/10.1056/NEJMp2313222

Medically Tailored Meals to Address the Health ... Quantitative evaluation revealed that receiving these meals substantially improved diet quality (difference in the Healthy Eating Index score, 31.4 points [3 SD]) ...

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

Evidence Assessment Library - Medically Tailored Meals This assessment synthesizes the results of studies on medically tailored meals across three domains of measurement:.

6. guidelinecentral.com guidelinecentral.com/clinical-trial/?id=NCT05026723

Food as Medicine for HIV and Diabetes Clinical Trial ... Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among ...