Food as Medicine for HIV and Diabetes

In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, "lack of access to enough food for an active, healthy life", is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications.

Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV.

The investigators has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention.

Thus, the investigators propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM or high risk for T2DM, referred for medically tailored meals. Adults with hemoglobin A1c less than 12.0%, and BMI ≥ 23 kg/m\^2 will be enrolled and randomly assigned to intervention or standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is weight at 6 months. Secondary outcomes include hemoglobin a1c, food security, quality of life, and diabetes distress.

• Bodyweight at Month 12 [Срок оценки: 12 months]
• Bodyweight at Month 18 [Срок оценки: 18 months]
• Hemoglobin A1c at Month 6 [Срок оценки: 6 months]
• Hemoglobin A1c at Month 12 [Срок оценки: 12 months]
• Hemoglobin A1c at Month 18 [Срок оценки: 18 months]
• Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6 [Срок оценки: 6 months]
• Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12 [Срок оценки: 12 months]
• Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18 [Срок оценки: 18 months]
• Depressive Symptom Score at Month 6 [Срок оценки: 6 months]
• Depressive Symptom Score at Month 12 [Срок оценки: 12 months]
• Depressive Symptom Score at Month 18 [Срок оценки: 18 months]
• Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6 [Срок оценки: 6 months]