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

PROJECT SUMMARY/ABSTRACT
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.
Our research team 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
hemoglobin A1c, weight, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes
distress, compared with a standard medically tailored meal intervention.
Thus, we 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,
referred for medically tailored meals. Adults with hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25
kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) 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
hemoglobin A1c at 6 months. Secondary outcomes include weight, food security, quality of life, and diabetes
distress.

Grant Number: 5R01DK127365-05
NIH Institute/Center: NIH
Principal Investigator: Seth Berkowitz