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RECRUITINGINTERVENTIONAL

Food as Medicine for HIV and Diabetes

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form and participate in all study activities Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

MTM + ILI

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

BEHAVIORAL

Standard 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