Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes (FAME-H Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of North Carolina, Chapel Hill
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.
Is the treatment Medically Tailored Meals and Intensive Lifestyle Intervention a promising treatment for people with HIV and Type 2 Diabetes?Yes, the treatment is promising because it combines healthy, pre-prepared meals with lifestyle changes to help manage chronic conditions like HIV and Type 2 Diabetes. This approach can improve health by ensuring access to nutritious food, which is crucial for managing these diseases. It also has the potential to reduce healthcare costs by preventing complications related to poor diet.13679
What safety data exists for Medically Tailored Meals and Lifestyle Intervention for HIV and Type 2 Diabetes?The available research does not directly address safety data for the specific combination of Medically Tailored Meals and Lifestyle Intervention for HIV and Type 2 Diabetes. However, related studies suggest that medically tailored meals are generally considered safe and beneficial for managing chronic conditions like type 2 diabetes. The 'Food is Medicine' approach, which includes medically tailored meals, is gaining interest for its potential to integrate nutrition into healthcare. Additionally, nutrition interventions are recognized as essential in managing HIV, as noted by the American Dietetic Association. While these studies support the concept's safety and effectiveness, specific safety data for the combined intervention in HIV and Type 2 Diabetes is not explicitly provided in the available research.12479
What data supports the idea that Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes is an effective treatment?The available research shows that Medically Tailored Meals (MTM) can be effective for people with Type 2 Diabetes, especially those who struggle to access nutritious food. One study highlights that MTM helps improve health outcomes and reduces healthcare costs for food-insecure diabetic patients. This suggests that MTM can be a valuable part of managing Type 2 Diabetes. While the research specifically on HIV and Type 2 Diabetes is limited, the positive results for Type 2 Diabetes alone indicate potential benefits for those with both conditions.15689
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications like oral or intravenous glucocorticoids that affect blood sugar intermittently, you may not be eligible to participate.
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
I am 18 years old or older.
I have been diagnosed with HIV.
I have been diagnosed with Type 2 Diabetes or am at high risk for it.
Exclusion Criteria
My kidney function is severely reduced.
I do not have a stable place to live or keep food.
I have an illness that defines AIDS.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)Experimental Treatment1 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 MTMActive Control1 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 nearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
Community ServingsCollaborator
Massachusetts General HospitalCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
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)
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.
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.
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.
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.
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.
"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.
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.
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.