200 Participants Needed

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

(FAME-H Trial)

KR
Overseen ByKatharine Ricks, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.12345

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.12678

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.12469

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.

Research Team

SA

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
English speaking
See 6 more

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
See 9 more

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
  • 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.
Participant 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

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+

Findings from Research

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.
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.
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.
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]

References

Acceptability and effectiveness of chickpea sesame-based ready-to-use therapeutic food in malnourished HIV-positive adults. [2022]
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]
Reducing risk of Type 2 diabetes in HIV: a mixed-methods investigation of the STOP-Diabetes diet and physical activity intervention. [2021]
Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]
The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. [2023]
"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]
Effects of an HIV-Care-Program on immunological parameters in HIV-positive patients in Yaoundé, Cameroon: a cluster-randomized trial. [2021]
Position of the American Dietetic Association: Nutrition Intervention and Human Immunodeficiency Virus Infection. [2019]
A group intervention to improve body image satisfaction and dietary habits in gay and bisexual men living with HIV/AIDS. [2017]
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