RECRUITING

Food as Medicine for HIV and Diabetes

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Conditions

Diabetes Mellitus, Type 2HIV InfectionsPreDiabetesFood InsecuritySocioeconomic FactorsLifestyle Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-10-04
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05026723

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participant in diabetes, nutrition, or weight research intervention in last 12 months
  2. * Current AIDS defining illness
  3. * Another family member or household member is a study participant. Only one member of each household may take part in this study.
  4. * Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
  5. * Lack of safe, stable residence and ability to store meals
  6. * Lack of telephone
  7. * Pregnancy/breastfeeding or intended pregnancy in the next year
  8. * 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.
  9. * Advanced kidney disease (estimated creatinine clearance \< 30 ml/min)
  10. * Known drug or alcohol misuse in the past 6 months
  11. * Known psychosis or major psychiatric illness that prevents participation with study activities
  12. * Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar

Contacts and Locations

Study Contact

Katharine Ricks, PhD
CONTACT
919-843-6637
kathier1@email.unc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-04
Study Completion Date2027-02

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Food Insecurity
  • Socioeconomic Factors
  • Lifestyle Intervention

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • HIV Infections
  • PreDiabetes