Food as Medicine for HIV and Diabetes
Recruiting · NCT05026723 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
MTM + ILIStandard MTM
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
2 locations listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States