Food as Medicine for HIV and Diabetes
FAME-H
Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
2 other identifiers
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2021
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
December 11, 2025
December 1, 2025
4.8 years
August 23, 2021
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bodyweight at Month 6
Bodyweight measured in Kg
6 months
Secondary Outcomes (14)
Bodyweight at Month 12
12 months
Bodyweight at Month 18
18 months
Hemoglobin A1c at Month 6
6 months
Hemoglobin A1c at Month 12
12 months
Hemoglobin A1c at Month 18
18 months
- +9 more secondary outcomes
Other Outcomes (42)
Food Insecurity Score at Month 6
6 Months
Food Insecurity Score at Month 12
12 Months
Food Insecurity Score at Month 18
18 Months
- +39 more other outcomes
Study Arms (2)
Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)
EXPERIMENTALThe 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.
Standard MTM
ACTIVE COMPARATORThe 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.
Interventions
Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program
Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian
Eligibility Criteria
You may qualify if:
- Male or female
- Diagnosis of HIV
- Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus, defined as meeting CDC eligibility criteria for the diabetes prevention program. Specifically, an individual without a diagnosis of T2DM must 1) have had a blood test result in the prediabetes range within the past year (Hemoglobin A1C: 5.7-6.4% OR Fasting plasma glucose: 100-125 mg/dL OR Two-hour plasma glucose \[after a 75 g glucose load\]: 140-199 mg/dL), 2) Have been previously diagnosed with gestational diabetes, OR 3) have a high-risk result (score of 5 or higher) on the Prediabetes Risk Test (https://www.cdc.gov/prediabetes/pdf/Prediabetes-Risk-Test-Final.pdf)
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- Aged ≥18 years
- BMI ≥ 23 kg/m2
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
You may not qualify if:
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Current AIDS defining illness
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- Advanced kidney disease (estimated creatinine clearance \< 30 ml/min)
- Known drug or alcohol misuse in the past 6 months
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth A Berkowitz, MD, MPH
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Owing to the nature of the intervention, participants, providers, and many study staff will know to which group individual participants have been randomized. However, efforts will be made to keep the study statistician and outcome assessors blinded to randomization group during the course of the trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 30, 2021
Study Start
October 4, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.
- Access Criteria
- Unless otherwise required by NIH policy, ability to deidentify data, plan for secure storage of data and agreement to protect participant privacy, and relevant research question, to be assessed by study investigators.
Individual participant data (IPD) that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).