# A pragmatic randomized controlled trial assessing the impact of medically tailored meals and medical nutrition therapy via telehealth among patients with poorly controlled diabetes

> **NIH NIH R18** · THOMAS JEFFERSON UNIVERSITY · 2021 · $661,321

## Abstract

PROJECT SUMMARY
Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM)
do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved
access to food and nutrition education. Several innovative models for food services have emerged to address
patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S.
deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that
food can be as helpful as medicine in improving patient outcomes. While a handful of pilot studies have
demonstrated success of MTM in reducing healthcare utilization and hemoglobin A1c (HbA1c) among patients
with DM, no randomized trials have assessed the sustained impact of MTM on long-term outcomes for patients
with DM. Similarly, individual studies of medical nutrition therapy (MNT), which includes individualized nutrition
education and counseling, have shown benefit for improving DM outcomes. However, uptake of MNT across
health systems has historically been extremely limited because of patient logistical barriers to attending the in-
person visits. MNT delivered by telehealth (tele-MNT) has potential to overcome these barriers. Our goal is to
evaluate the effect of MTM, with and without additional tele-MNT, on outcomes for patients with poorly
controlled type 2 DM. We will conduct a pragmatic randomized controlled trial with patients who have poorly
controlled DM. Outcomes of interest include change in HbA1c, cost effectiveness, weight, diabetes self-
efficacy, self-care, diabetes quality of life, and patient satisfaction. We will assess the efficacy of 1) MTM and
2) MTM + tele-MNT compared to usual care in reducing HbA1c at 3, 6 (primary outcome) and 12 months and
the cost effectiveness of each intervention compared to usual care up to 12 months. We will also explore
patient perspectives regarding experiences with MTM and MTM + tele-MNT to gain a better understanding of
potential factors contributing to treatment failure and success within each group. The proposed research is
innovative because it develops and tests a novel tele-MNT intervention tailored to recipients of MTM, provides
a comprehensive solution to patient-identified nutrition needs, includes complete utilization data provided by
the HealthShare Exchange, and leverages a unique health system and community group partnership to
improve sustainability and scalability. Study results will inform 1) provider and payor decisions regarding
offering and covering these services; 2) how services should be structured for scalability; and 3) integration of
these services into the larger care delivery system to reduce DM disparities.

## Key facts

- **NIH application ID:** 10206125
- **Project number:** 5R18DK118590-03
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** Kristin Laura Rising
- **Activity code:** R18 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $661,321
- **Award type:** 5
- **Project period:** 2019-07-18 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10206125

## Citation

> US National Institutes of Health, RePORTER application 10206125, A pragmatic randomized controlled trial assessing the impact of medically tailored meals and medical nutrition therapy via telehealth among patients with poorly controlled diabetes (5R18DK118590-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10206125. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*