# Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $686,227

## Abstract

ABSTRACT
In the United States, 29.1 million persons live with type 2 diabetes mellitus (T2DM) and 49 million persons are
food-insecure, both disproportionately impacting low-income communities. Food insecurity is strongly associated
with the development of T2DM and, among people with T2DM, poor glycemic control, operating through
nutritional, mental health, and behavioral pathways. Existing nutrition safety-net resources are inadequate to
address the health effects of food insecurity. Policy makers increasingly recognize the premise that “Food is
Medicine” - i.e. that medically tailored food support for chronically ill, food-insecure people can play a critical role
in achieving optimal health outcomes. In collaboration with Project Open Hand, a large non-profit nutrition agency
that provides medically tailored meals and groceries to low-income, chronically ill residents of the San Francisco
Bay Area, we propose a randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes
(CHEFS-DM). CHEFS-DM is a six-month intervention providing a DM-tailored diet meeting approximately 75%
of daily energy requirements and designed based on American Diabetes Association guidelines, together with
DM nutritional education provided by registered dieticians. In our pilot study, the intervention was feasible,
acceptable, and associated with improvements in food security, diet quality, health behaviors, mental health, and
trends towards improvements in acute care use and DM control. In this pragmatic RCT, we propose to rigorously
evaluate the intervention among 400 low-income adults with T2DM recruited from networks of safety net clinics
in San Francisco and Alameda counties, California. Leveraging POH's real-world programs, we will randomize
participants 1:1 to intervention and control arms, following all participants with surveys, blood pressure
measures, anthropometry, 24-hour recalls, medical record review and fasting blood draws at baseline and six
months to assess intervention impacts on health outcomes; intervention participants will complete an additional
twelve-month assessment to assess sustainability. In Aim 1, we will determine the impact of CHEFS-DM on
diabetes health, hypothesizing the intervention will improve hemoglobin A1c (primary outcome) and other
cardiometabolic outcomes [decreased fasting glucose, blood pressure (BP), lipids, acute care utilization, DM
medication intensification and increased health-related quality of life (HRQoL)] (secondary outcomes). In Aim 2,
we will use our published conceptual framework to understand the nutritional, mental, and behavioral paths
through which CHEFS-DM may impact T2DM health outcomes. Finally, in Aim 3, we will determine the cost-
effectiveness and sustainability of CHEFS-DM, and conduct a mixed-methods process evaluation to understand
intervention strengths and limitations to inform scale-up. We hypothesize that the intervention may be cost-
effective and possibly even cost saving,...

## Key facts

- **NIH application ID:** 10135957
- **Project number:** 5R01DK124630-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Kartika Palar
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $686,227
- **Award type:** 5
- **Project period:** 2020-04-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10135957

## Citation

> US National Institutes of Health, RePORTER application 10135957, Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health (5R01DK124630-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10135957. Licensed CC0.

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