Food as Medicine for HIV and Diabetes

Description

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.

Conditions

Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes

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Study Overview

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Study Details

Study overview

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.

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

Food as Medicine for HIV and Diabetes

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

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

Study Record Dates

2027-02