NCT05026723Active, not recruiting
Food as Medicine for HIV and Diabetes
Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Aug 2021
- Start date
- 4 Oct 2021
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV, Type 2 diabetes
- NCT number
- NCT05026723
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 4 Oct 2021 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Known drug or alcohol misuse in the past 6 months
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Other illness
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Current AIDS defining illness
- Known psychosis or major psychiatric illness that prevents participation with study activities
Lab values
- Advanced kidney disease (estimated creatinine clearance \< 30 ml/min)
Age
- 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.
Other
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.