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Food as medicine: new study tests meals and coaching for HIV and diabetes

NCT ID NCT05026723

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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Other studies related to the condition(s) this trial covers.