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Behavioral Intervention

Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes (FAME-H Trial)

N/A
Recruiting
Led By Seth A Berkowitz, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥18 years
Diagnosis of HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

FAME-H Trial Summary

This trial is testing whether a combination of a medically tailored meal and an intensive lifestyle intervention can help adults with food insecurity, HIV, and Type 2 diabetes, compared to those who just receive a medically tailored meal.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve medically tailored meals and lifestyle changes rather than medications, side effects may include dietary adjustments or discomfort from new physical activities but are generally expected to be minimal.

FAME-H Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with HIV.
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I have been diagnosed with Type 2 Diabetes or am at high risk for it.
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I am either male or female.

FAME-H Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bodyweight at Month 6
Secondary outcome measures
Bodyweight at Month 12
Bodyweight at Month 18
Depressive Symptom Score at Month 12
+11 more
Other outcome measures
ARMS-D Medication Adherence Score at Month 12
ARMS-D Medication Adherence Score at Month 18
Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6
+39 more

FAME-H Trial Design

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.

Find a Location

Who is running the clinical trial?

Community ServingsUNKNOWN
3 Previous Clinical Trials
306 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,186,518 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,924 Previous Clinical Trials
13,193,223 Total Patients Enrolled

Media Library

MTM + ILI (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05026723 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI), Standard MTM
Human Immunodeficiency Virus Infection Clinical Trial 2023: MTM + ILI Highlights & Side Effects. Trial Name: NCT05026723 — N/A
MTM + ILI (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026723 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrolment size for this investigation?

"Affirmative. The information hosted on clinicaltrials.gov attests to this research study being open for recruitment. It was first published on October 4th, 2021 and the last revision occurred in August 3rd of 2022; seeking 200 participants from a single centre."

Answered by AI

Is enrollment for the trial currently open?

"Affirmative. This clinical trial is actively recruiting as indicated on the data available through clinicaltrials.gov. The study was first listed on October 4th 2021 and underwent its last update on August 3rd 2022, seeking 200 individuals from a single location for participation."

Answered by AI
~98 spots leftby Aug 2026