Food as Medicine for HIV and Diabetes

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes

In brief

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 facts

Study ID

NCT05026723

Run by

University of North Carolina, Chapel Hill

People needed

200

Starts

2021-10-04

Expected to finish

2027-02-01

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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