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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07748286
Enrollment
150
Registered
2026-08-05
Start date
2022-01-01
Completion date
2024-09-16
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes (DM), Nutrition

Keywords

diabetes, food as medicine, nutrition

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. 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.

Interventions

BEHAVIORALFood 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.

BEHAVIORALIndiana 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

Indiana University
Lead SponsorOTHER
Indiana University Health
CollaboratorOTHER
Eskenazi Health
CollaboratorOTHER
Purdue University
CollaboratorOTHER
Direct Relief
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* n/a

Design outcomes

Primary

MeasureTime frameDescription
HbA1c Change at 6 to 9 months9 monthsChange in HbA1c from baseline and at 6.1 to 9 months after intervention

Secondary

MeasureTime frameDescription
HbA1c change at other time points1 yearThe change in Hba1c from baseline to 3.1 to 6 months and 9.1 to 12 months was evaluated

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026