Food as medicine: new study tests meals and coaching for HIV and diabetes
NCT ID NCT05026723
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study tests whether providing medically tailored meals along with intensive lifestyle coaching can help adults with HIV and type 2 diabetes or prediabetes better manage their weight and blood sugar. About 200 participants will be randomly assigned to receive either the meals plus coaching or meals alone. The goal is to see if this approach improves health outcomes over 18 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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