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Food as Medicine for HIV and Diabetes

This study is looking at how different food programs can help adults who have HIV and either Type 2 Diabetes (T2DM) or are at high risk for it. You might be able to join if you are an adult with HIV and T2DM, or if you meet the CDC criteria for prediabetes. The study compares two approaches: one involves weekly home-delivered meals that are medically tailored, along with a 20-session telephone lifestyle program (MTM + ILI). The other approach provides weekly home-delivered medically tailored meals and an initial meeting with a dietitian (Standard MTM). The main goal is to see how these programs affect body weight after 6 months. The study is currently unclear about its recruitment status.

Study design
This is a randomized controlled study involving 200 participants. It is an open-label study, meaning both you and the study staff will know which intervention you are receiving.
What's involved
You would receive weekly home meal deliveries. Depending on your assigned group, you would also participate in either a 20-session telephone lifestyle intervention or an initial consultation with a dietitian.
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be measured at 6 months to assess the study's primary outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05026723

Food as Medicine for HIV and Diabetes

Recruiting
NAAges 18+InterventionalTreatment
University of North Carolina, Chapel Hill
~200 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:MTM + ILIStandard MTM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bodyweight at Month 6
Measured over 6 months

Conditions

Diabetes Mellitus, Type 2
HIV Infections
PreDiabetes

Explore related trials

HIV InfectionPrediabetesType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Seth A Berkowitz, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Katharine Ricks, PhD
[email protected]
919-843-6637
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Bodyweight at Month 66 months

    Bodyweight measured in Kg