Food as Medicine for HIV and Diabetes

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05026723
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MTM + ILI — BEHAVIORAL
    Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program
  • Standard MTM — BEHAVIORAL
    Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian

Study Details

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.

Key Dates

Start date
Oct 4, 2021
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)
    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.
  • Active Comparator: Standard MTM
    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.

Primary Outcome Measure

Bodyweight at Month 6 [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Katharine Ricks, PhD

Find similar trials in Chapel Hill, NC

By condition
Type 2 diabetesHIV
By specialty
EndocrinologyMetabolic healthWeight lossInfectious disease
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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