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

NCT07748286 | Completed

• 1 other identifier: 15333
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

diabetes; food as medicine; nutrition

Outcome Measures

Primary Outcomes (1)

• HbA1c Change at 6 to 9 months

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

  9 months

Secondary Outcomes (1)

• HbA1c change at other time points

  1 year

Study Arms (2)

Eskenazi Health Diabetes Clinics

ACTIVE COMPARATOR

This arm included patients living with diabetes who were receiving care at Eskenazi Health.

Behavioral: Food as Medicine Eskenazi

Indiana Health East Washington Diabetes Clinic

ACTIVE COMPARATOR

This arm includes patients living with diabetes and receiving diabetes care at Indiana Health's East Washington Clinic.

Behavioral: Indiana Health NourishedRX

Interventions

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.

Eskenazi Health Diabetes Clinics

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.

Indiana Health East Washington Diabetes Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator
• Eskenazi Health: collaborator
• Purdue University: collaborator
• Direct Relief: collaborator

Study Sites (1)

Eskenazi Health / Indiana Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Food

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Medicine

Model Details: The study was an observational intervention study assessing the outcomes of the integration of a food as medicine into routine diabetes care

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: January 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: September 16, 2024
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: It will only be available upon reasonable request
• Access Criteria: It will only be available upon reasonable request from researchers

Locations

US (1)