Using tailored meals and lifestyle changes to help people with HIV and diabetes
Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
This study is testing if personalized meal plans and lifestyle changes can help adults with HIV and diabetes who struggle with food insecurity feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05026723 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a medically tailored meal and intensive lifestyle intervention (MTM + ILI) for adults facing food insecurity who are living with HIV and type 2 diabetes or at high risk for it. Participants will be randomly assigned to receive either the MTM + ILI intervention or standard medically tailored meals. The study aims to address the unique health challenges faced by this population, including the increased prevalence of diabetes and food insecurity among individuals with HIV. By providing personalized meal plans and lifestyle support, the trial seeks to improve health outcomes and quality of life for participants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are diagnosed with HIV, have type 2 diabetes or are at high risk for it, and experience food insecurity.
Not a fit: Patients who do not have HIV or type 2 diabetes, or those who are not experiencing food insecurity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve diabetes management and overall health for individuals living with HIV and food insecurity.
How similar studies have performed: Other studies have shown promising results with similar interventions targeting food insecurity and chronic conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Seth A Berkowitz, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Katharine Ricks, PhD
- Email: kathier1@email.unc.edu
- Phone: 919-843-6637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.