RecruitingNot ApplicableNCT05026723

Food as Medicine for HIV and Diabetes

Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention


Sponsor

University of North Carolina, Chapel Hill

Enrollment

200 participants

Start Date

Oct 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a "food as medicine" program — providing healthy, medically tailored meals and nutrition support — can improve blood sugar control and overall health in people who are living with both HIV and type 2 diabetes (or prediabetes) and who struggle with food insecurity. **You may be eligible if...** - You are 18 or older - You have HIV - You have been diagnosed with type 2 diabetes, OR you have prediabetes (as shown by a recent blood test), OR you previously had gestational diabetes - You are experiencing food insecurity (difficulty affording food) - You speak English and have a BMI of 23 or higher - You plan to stay in the area for at least 1 year **You may NOT be eligible if...** - You participated in a diabetes, nutrition, or weight-loss research program in the last 12 months - You have an active AIDS-defining illness - You do not control your own food choices (e.g., living in a facility) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMTM + ILI

Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program

BEHAVIORALStandard MTM

Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian


Locations(1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT05026723


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