Diabetes (DM)NCT07748286
Impact of Food as Medicine Glycemic Control at Two Large Academic Medical Centers
A study testing Food as Medicine Eskenazi and Indiana Health NourishedRX in people with Diabetes (DM) and Nutrition, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM), Nutrition
- What is being tested?
- Food as Medicine Eskenazi and Indiana Health NourishedRX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- some form of diabetes
- receiving care at an Eskenazi FQHC or the Indiana Health East Washington Clinic
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
Eskenazi Health / Indiana Health
Indianapolis, Indiana, 46202
About this study
Official title: Evaluating the Impact of a Comprehensive Food as Medicine Intervention on 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.
- 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.
- 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
- Being tested
- Food as Medicine Eskenazi, Indiana Health NourishedRX
- Keywords
- diabetes, food as medicine, nutrition
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food as Medicine EskenaziBehavioural
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 NourishedRXBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Eskenazi Health Diabetes Clinics | Active comparator | This arm included patients living with diabetes who were receiving care at Eskenazi Health. Receives: 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. Receives: Behavioral: Indiana Health NourishedRX |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Change at 6 to 9 months
Change in HbA1c from baseline and at 6.1 to 9 months after intervention
Measured: 9 months
Secondary outcomes (1)
HbA1c change at other time points
The change in Hba1c from baseline to 3.1 to 6 months and 9.1 to 12 months was evaluated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jan 2022
- Primary completion20 Dec 2023
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study was an observational intervention study assessing the outcomes of the integration of a food as medicine into routine diabetes care
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health, Purdue University, Direct Relief
- Responsible party
- Principal investigator, Sonak Pastakia, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748286
- Sponsor's protocol ID
- 15333
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We do not have approval to share individual identifiable participant data. Only de-identified data would be shared with other researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Comprehensive Food as Medicine Intervention on Glycemic Control at Two Large Academic Medical Centers
- ClinicalTrials.gov ID
- NCT07748286
- Acronym / sponsor ID
- 15333
- Conditions
- Diabetes (DM), Nutrition
- Keywords
- diabetes, food as medicine, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health, Purdue University, Direct Relief
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was an observational intervention study assessing the outcomes of the integration of a food as medicine into routine diabetes care
| Arm | Type | Receives |
|---|---|---|
| Eskenazi Health Diabetes Clinics | Active comparator | Behavioral: Food as Medicine EskenaziThis arm included patients living with diabetes who were receiving care at Eskenazi Health. |
| Indiana Health East Washington Diabetes Clinic | Active comparator | Behavioral: Indiana Health NourishedRXThis arm includes patients living with diabetes and receiving diabetes care at Indiana Health's East Washington Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- some form of diabetes
- receiving care at an Eskenazi FQHC or the Indiana Health East Washington Clinic
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food as Medicine EskenaziThe 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. | Behavioural | Eskenazi Health Diabetes Clinics |
| Indiana Health NourishedRXOnce 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. | Behavioural | Indiana Health East Washington Diabetes Clinic |
Primary outcome
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
1 secondary outcome
HbA1c change at other time points
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. We do not have approval to share individual identifiable participant data. Only de-identified data would be shared with other researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food as Medicine Eskenazi and Indiana Health NourishedRX in people with Diabetes (DM) and Nutrition, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Change at 6 to 9 months (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.