Impact of Food as Medicine Glycemic Control at Two Large Academic Medical Centers

NCT07748286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-05

No results posted yet for this study

Summary

The primary purpose of this study is to determine if the implementation of a food as medicine program would improve clinical outcomes when integrated into routine care at two large academic hospitals.

1. Determine if the FRESH Program's methods of addressing food insecurity improves clinical outcomes, reduces emergency room visits, and reduces hospital admissions for patients with diabetes, cardiovascular disease, surgery, and/or recent COVID-19 hospital admission.
2. Determine the feasibility and scalability of the FRESH Program nutrition intervention within two separate health systems in order to inform future state and federal policies governing reimbursement for nutritional interventions that improve food insecurity.

Conditions

  • Diabetes (DM)
  • Nutrition

Interventions

BEHAVIORAL

Food as Medicine Eskenazi

The FRESH Program intervention provided four additional nutrition classes conducted weekly by dietitians. Prior to each class, participants were given a food kit with all the necessary ingredients to make a recipe taught in class in the upcoming week. During this time, participants were also sent ten freshly prepared medically tailored meals packaged within the Eskenazi Health Hospital kitchen and delivered to participant homes weekly. After the first month, participants were given $90 monthly fresh produce vouchers that were usable at local grocery stores. The intervention lasted for a total of 20 weeks. Another key component of the intervention was to ensure patients had essential cooking equipment to prepare recipes covered in the class. At baseline, study participants were given a basic kitchen utensil kit (i.e. measuring cups, measuring spoons) and were provided additional cooking instruments such as microwaves and pots and pans as needed.

BEHAVIORAL

Indiana Health NourishedRX

Once IU Health identified eligible candidates, participants were referred to an external vendor, NourishedRx, which provided nutrition consultations with dietitians, and personalized nutrition plans for participants according to cultural preferences. NourishedRx then sent medically tailored meals for two weeks followed by fresh groceries for twelve weeks. NourishedRx staff also engaged patients weekly to support participants in making lasting dietary changes as a result of the program.

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER
  • Eskenazi Health

    collaborator OTHER
  • Purdue University

    collaborator OTHER
  • Direct Relief

    collaborator UNKNOWN
  • Indiana University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-20
Completion
2024-09-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748286 on ClinicalTrials.gov