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}

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.

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

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

Community Servings Collaborator

Community Servings Collaborator

Massachusetts General Hospital Collaborator

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

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] 'Food is medicine' strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. 'Medically Tailored Meals' (MTM) is one such intervention, which involves the 'prescription' by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education.

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] A prospective descriptive study to assess acceptability and effectiveness of a locally made ready-to-use therapeutic food (RUTF) in HIV-infected chronically sick adults (CSA) with mid-upper-arm circumference (MUAC)

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] To conduct a mixed-methods feasibility study of the effectiveness and acceptability of an individualized diet and physical activity intervention designed to reduce the risk of Type 2 diabetes experienced by people living with HIV.

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

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020] Type 2 diabetes mellitus is an immense burden to the health of our population and to our current health care system, and the weight of this burden is only projected to multiply in coming years. A nutritious diet is an indispensable aspect of diabetes treatment, and the lack of access to food engenders poor disease-state control, which correlates with increased health care utilization. Interventions aimed at improving access to food through medically tailored meals (MTMs) have demonstrated effectiveness in improving the health of food-insecure type 2 diabetic patients and reducing health care costs. Further studies are necessary to increase the external validity of existing positive research on medically tailored meals in food-insecure diabetic patients and to provide evidence to support potential policy changes under which the costs of medically tailored meals for diabetics might be covered by insurers.

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] Type 2 Diabetes (T2DM) is a global health crisis affecting 10.5% adults worldwide. The numbers are even higher in the United States with currently 11.3% of all Americans diagnosed with T2DM. Research has confirmed that medical nutrition therapy (MNT) including a customized diet and coaching support can be an effective tool for diabetes care. In this report we describe two cases in which MNT improved glycemic control, helped to reach, and maintain a healthy weight, and reduced critical cardiovascular risk factors. This report shows that a personalized nutrition program combined with coaching by certified experts can be an effective tool in the daily diabetes practice.

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] To measure the effects of an HIV-Care-Program, focusing on nutrition and lifestyle, which can be provided at scale to HIV-infected patients, on clinical and anthropometrical parameters, and health status.

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] Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants.

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

Position of the American Dietetic Association: Nutrition Intervention and Human Immunodeficiency Virus Infection. [2019] It is the position of the American Dietetic Association that efforts to optimize nutritional status through individualized medical nutrition therapy, assurance of food and nutrition security, and nutrition education are essential to the total system of health care available to people with human immunodeficiency virus (HIV) infection throughout the continuum of care. Broad-based efforts to improve health care access and treatment have stabilized HIV prevalence levels in many parts of the world and led to longer survival for people living with HIV infection. Confounding clinical and social issues, such as medication interactions, comorbidities, wasting, lipodystrophy, food insecurity, aging, and other related conditions further complicate disease management. With greater understanding of the mechanisms of HIV disease and its impact on body function, development of new treatments, and wider ranges of populations affected, the management of chronic HIV infection continues to become more complex and demanding. Achievement of food and nutrition security and management of nutrition-related complications of HIV infection remain significant challenges for clients with HIV infection and health care professionals. Registered dietitians and dietetic technicians, registered, should integrate their efforts into the overall health care strategies to optimize their clinical and social influence for people living with HIV infection.

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] A healthy diet is essential to maintaining a strong immune system for people living with HIV and AIDS. Prior studies have shown that HIV-positive gay and bisexual men are more susceptible to poor body image, which can negatively impact dietary habits. Interventions that simultaneously address body image and nutrition are therefore critical for this population. This paper describes the curriculum for a 14-week group designed to improve body image satisfaction and dietary habits in gay and bisexual men living with HIV/AIDS.