Diabetes MellitusNCT05896644
Eat Well Produce Benefit for Diabetes and Food Insecurity
A study testing Eat Well in people with Diabetes Mellitus and Food Insecurity, run by Duke University at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are: whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Food Insecurity
- What is being tested?
- Eat Well
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,177 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 1 May 2026
- 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
- Be active in the Duke Diabetes Registry in the past 12 months AND
- have had at least one outpatient A1c measurement AND
- are at risk for food insecurity as defined by one of the following:
- answered often true or sometimes true on one or both of the food insecurity questions as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
- answered hard or very hard to the financial stress question as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
- has Medicaid as insurance payer OR
- lives in Area Deprivation Index (ADI) zip code of 7th decile or harder
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27708
About this study
Official title: An Evaluation of Eat Well, a Produce Benefit, for Patients With Diabetes and At-risk for Food Insecurity
The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are:
- whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion.
- whether there are differences in cardiometabolic health-related outcomes for Eat Well participants.
Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.
Read the detailed description
This pragmatic trial aims to assess the impact of Eat Well participation for diabetes patients at risk of food insecurity. Eligible patients will receive gift/debit cards for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-approved fruits and vegetables and be assigned to either receive the card for up to 12 months or not. Random assignment will occur using a 2 to 1 treatment to control allocation ratio. Both treatment and control groups will receive curated diabetes educational materials. The study will assess the impact of the intervention on clinical factors such as glycemic control, weight, BMI, lipids, medication adherence, medication number, blood pressure, and utilization up to 18 months pre, during, and post program enrollment using data from clinical visits. The primary analysis of interest will be differences in HbA1c measurements and ED visits between the Eat Well and control groups at 12 months of program participation, with further evaluation of differences at 12 months post-program completion.
- Conditions
- Diabetes Mellitus, Food Insecurity
- Being tested
- Eat Well
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat WellOther
A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Eat Well | Experimental | The experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System. Receives: Other: Eat Well |
| Control | No intervention | The control group will receive usual care (including diabetes educational materials) without the prescription benefit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
A measure of average blood sugar levels over the past 3 months.
Measured: 18 months pre program, during program enrollment, up to 12 months
Change in number of ED Visits
Number of ED visits throughout the study period
Measured: up to 18 months pre program, during program enrollment, up to 12 months
Secondary outcomes (10)
Outpatient visits
Number of outpatient visits during the study period
Measured: up to 18 months pre program, during program, and up to 18 months post program
Hospitalizations
Number of patient hospitalizations during the study period
Measured: up to 18 months pre program, during program, and up to 18 months post program
Change in weight
Measured: up to 18 months pre program, during program, and up to 18 months post program enrollment
Change in body mass index (BMI)
A measure of body fat based on height and weight.
Measured: up to 18 months pre program, during program, and up to 18 months post program
Change in cholesterol
Measure of lipids
Measured: up to 18 months pre program, during program, and up to 18 months post program
Medication adherence (proportion of days covered)
Medication adherence will be measured by linking EHR data with Surescripts e-prescription network data. Surescripts facilitates medication refill information exchange between healthcare organizations and pharmacies. Adherence will be calculated using the proportion of days covered (PDC) approach
Measured: up to 18 months pre program, during program, and up to 18 months post program
Change in number of diabetes and hypertension medications
Change in diabetes and hypertension medication numbers
Measured: up to 18 months pre program, during program, and up to 18 months post program
Change in blood pressure
Systolic and Diastolic blood pressure
Measured: up to 18 months pre program, during program, and up to 18 months post program
Change in HbA1C
A measure of average blood sugar levels over the past 3 months.
Measured: 18 months post program
Change in number of ED Visits
Number of ED visits throughout the study period
Measured: 18 months post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start20 Jun 2023
- Primary completion16 Jul 2024
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Duke 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896644
- Sponsor's protocol ID
- Pro00112649
- Status last verified
- May 2026
- First submitted
- 26 May 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to all participant data and information will be restricted to authorized personnel. Internal monitoring of data may occur as required by Duke for investigator-initiated clinical research.
Publications
Rader A, Buckman C, Pignone M, German JC, Spratt SE, McPeek Hinz E, Brucker A, Hoeffler S, Kane RM, Drake C. Factors Associated with Produce Prescription Program Enrollment and Benefit Use among Patients with Diabetes and at Risk for Food Insecurity. J Nutr. 2026 Jun;156(6):101548. doi: 10.1016/j.tjnut.2026.101548. Epub 2026 Apr 25.
PubMed 42036037Drake C, Buckman C, Brucker A, McPeek Hinz E, Pignone M, Shaikha H, Rader A, Granados I, Goldstein BA, Chamorro C, Hoeffler S, Wirth C, Spratt SE. Produce Prescription Subsidy for Patients With Diabetes: A Pragmatic Randomized Clinical Trial. JAMA Intern Med. 2026 Apr 1;186(4):416-424. doi: 10.1001/jamainternmed.2025.8008.
PubMed 41697676Drake C, Granados I, Rader A, Brucker A, Hoeffler S, Goldstein BA, Chamorro C, Johnson F, Hinz EM, Bedoya AD, German JC, Hauser J, Thacker C, Spratt SE. Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107655. doi: 10.1016/j.cct.2024.107655. Epub 2024 Aug 5.
PubMed 39111387
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Eat Well, a Produce Benefit, for Patients With Diabetes and At-risk for Food Insecurity
- ClinicalTrials.gov ID
- NCT05896644
- Acronym / sponsor ID
- Pro00112649
- Conditions
- Diabetes Mellitus, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,177 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 9 Jun 2023 (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 goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are:
- whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion.
- whether there are differences in cardiometabolic health-related outcomes for Eat Well participants.
Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.
Detailed description
This pragmatic trial aims to assess the impact of Eat Well participation for diabetes patients at risk of food insecurity. Eligible patients will receive gift/debit cards for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-approved fruits and vegetables and be assigned to either receive the card for up to 12 months or not. Random assignment will occur using a 2 to 1 treatment to control allocation ratio. Both treatment and control groups will receive curated diabetes educational materials. The study will assess the impact of the intervention on clinical factors such as glycemic control, weight, BMI, lipids, medication adherence, medication number, blood pressure, and utilization up to 18 months pre, during, and post program enrollment using data from clinical visits. The primary analysis of interest will be differences in HbA1c measurements and ED visits between the Eat Well and control groups at 12 months of program participation, with further evaluation of differences at 12 months post-program completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eat Well | Experimental | Other: Eat WellThe experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System. |
| Control | No intervention | –The control group will receive usual care (including diabetes educational materials) without the prescription benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be active in the Duke Diabetes Registry in the past 12 months AND
- have had at least one outpatient A1c measurement AND
- are at risk for food insecurity as defined by one of the following:
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Eat WellA program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables. | Other | Eat Well |
Primary outcome
Change in HbA1C
Time frame: 18 months pre program, during program enrollment, up to 12 months
A measure of average blood sugar levels over the past 3 months.
Change in number of ED Visits
Time frame: up to 18 months pre program, during program enrollment, up to 12 months
Number of ED visits throughout the study period
10 secondary outcomes
Outpatient visits
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Hospitalizations
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Change in weight
Time frame: up to 18 months pre program, during program, and up to 18 months post program enrollment
Change in body mass index (BMI)
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Change in cholesterol
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Medication adherence (proportion of days covered)
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Change in number of diabetes and hypertension medications
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Change in blood pressure
Time frame: up to 18 months pre program, during program, and up to 18 months post program
Change in HbA1C
Time frame: 18 months post program
Change in number of ED Visits
Time frame: 18 months post program
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 8 May 2026.
- Derived from this study: PubMed 42036037Rader A, Buckman C, Pignone M, German JC, Spratt SE, McPeek Hinz E, Brucker A, Hoeffler S, Kane RM, Drake C. Factors Associated with Produce Prescription Program Enrollment and Benefit Use among Patients with Diabetes and at Risk for Food Insecurity. J Nutr. 2026 Jun;156(6):101548. doi: 10.1016/j.tjnut.2026.101548. Epub 2026 Apr 25.
- Derived from this study: PubMed 41697676Drake C, Buckman C, Brucker A, McPeek Hinz E, Pignone M, Shaikha H, Rader A, Granados I, Goldstein BA, Chamorro C, Hoeffler S, Wirth C, Spratt SE. Produce Prescription Subsidy for Patients With Diabetes: A Pragmatic Randomized Clinical Trial. JAMA Intern Med. 2026 Apr 1;186(4):416-424. doi: 10.1001/jamainternmed.2025.8008.
- Derived from this study: PubMed 39111387Drake C, Granados I, Rader A, Brucker A, Hoeffler S, Goldstein BA, Chamorro C, Johnson F, Hinz EM, Bedoya AD, German JC, Hauser J, Thacker C, Spratt SE. Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107655. doi: 10.1016/j.cct.2024.107655. Epub 2024 Aug 5.
- Resource guide to be provided to all patients, regardless of selection in intervention or control groupLink provided by the sponsor.
- Link provided to all patients to find diabetes self management education and support in their areaLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to all participant data and information will be restricted to authorized personnel. Internal monitoring of data may occur as required by Duke for investigator-initiated clinical research.
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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 Eat Well in people with Diabetes Mellitus and Food Insecurity, run by Duke 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 7 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 8 May 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?
Change in HbA1C (time frame: 18 months pre program, during program enrollment, up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896644, which also lists 3 linked publications.
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 8 May 2026.