Actively Recruiting
Food as Medicine for HIV and Diabetes
Led by University of North Carolina, Chapel Hill · Updated on 2025-12-11
200
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
C
Community Servings
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Food as Medicine for HIV and Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Diagnosis of HIV
- Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus as defined by CDC diabetes prevention program criteria
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- Aged 18 years or older
- BMI 23 kg/m2 or higher
- No plans to move from the area for at least 1 year
- Living independently with control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
You will not qualify if you...
- Participation in diabetes, nutrition, or weight research intervention in last 12 months
- Current AIDS defining illness
- Another family or household member is a study participant (only one member per household allowed)
- Considering bariatric surgery in the next year or bariatric surgery in past 2 years
- Lack of safe, stable residence or ability to store meals
- Lack of telephone access
- Pregnancy, breastfeeding, or planned pregnancy in next year
- History of malignancy except non-melanoma skin cancer unless cured or in remission for over 5 years
- Advanced kidney disease (creatinine clearance below 30 ml/min)
- Known drug or alcohol misuse in past 6 months
- Known psychosis or major psychiatric illness preventing study participation
- Intermittent use of medications affecting blood sugar such as glucocorticoids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
K
Katharine Ricks, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here