Skip to main content
OpenTrials
Completed

NCT Number: NCT07748286

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health / Indiana Health

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • some form of diabetes
  • receiving care at an Eskenazi FQHC or the Indiana Health East Washington Clinic

Exclusion criteria

  • n/a

Treatment and study plan

Food as Medicine Eskenazi

Behavioral

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.

Indiana Health NourishedRX

Behavioral

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.

Primary outcomes

  1. HbA1c Change at 6 to 9 months

    Time frame: 9 months

    Change in HbA1c from baseline and at 6.1 to 9 months after intervention

Secondary outcomes

  1. HbA1c change at other time points

    Time frame: 1 year

    The change in Hba1c from baseline to 3.1 to 6 months and 9.1 to 12 months was evaluated

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Direct Relief
  • Eskenazi Health
  • Indiana University Health
  • Purdue University

Registry information

Official study title

Evaluating the Impact of a Comprehensive Food as Medicine Intervention on Glycemic Control at Two Large Academic Medical Centers

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.