Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals with Type 2 Diabetes Mellitus and Food Insecurity

PROJECT SUMMARY/ABSTRACT
Food insecurity, “lack of access to enough food for an active, healthy life”, affects over 20% of the 30 million
Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower
socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased
complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in
diabetes outcomes.
Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes
and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to
the specific medical needs of the individual, and provide education to help optimize disease self-management.
Food insecurity is typically addressed with food subsidies—offering additional financial resources that can be
spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help
overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed
to prepare appropriate meals. The use of these programs is often called ‘food is medicine’, as the purpose is to
provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public
attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared
with other food insecurity interventions.
Our research team has developed a medically tailored meal intervention that combines provision of healthy
food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that
uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving
meals and after meal delivery is completed. MTM was highly successful in improving diet quality in a pilot
randomized clinical trial. What is missing is an explanatory (efficacy) randomized trial testing whether this
medically tailored meal intervention can lead to improvements in diabetes outcomes such as Hemoglobin A1c,
and in patient-reported outcomes such as diabetes distress, quality of life, and hypoglycemia.
Thus, we propose a randomized trial to assess a community-based medically tailored meals intervention
(n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type
2 diabetes, 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 usual care + food subsidy. The intervention
group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food
subsidy group will receive a $30/month healthy food subsidy, along with usual diabetes care. Outcomes will be
assessed at 6 and 12 months. The primary outcome is Hemoglobin A1c at 6 months. Secondary outcomes
include change in physiologic, behavioral, and psychosocial measures.

Grant Number: 5R01DK125831-05
NIH Institute/Center: NIH
Principal Investigator: Seth Berkowitz