Type 2 DiabetesGARDEN-CARDIONCT07674979
Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity
A study testing Produce Gift Card and Dietary Education in people with Type 2 Diabetes, run by West Virginia University at 1 site in United States.
Trial summary
This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Produce Gift Card and Dietary Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of type 2 diabetes mellitus
- Most recent HbA1c >8% within the prior 6 months
- Must have had a clinic visit within the past 6 months
- Positive screening for food insecurity based on the USDA 6-item food security survey
- Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics
- Able and willing to provide written informed consent
Who cannot join
- End-stage renal disease
- Advanced heart failure
- Severe cognitive impairment
- Chronic pancreatitis
- Pancreatic malignancy
- Pregnancy at time of enrollment
- Anticipated inability to utilize intervention vouchers (e.g., lack of access to Walmart)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Virginia University Heart and Vascular Institute
Morgantown, West Virginia, 26506
About this study
Official title: A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity
This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Produce Gift Card and Dietary Education, Usual Care
- Keywords
- Food Insecurity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Gift Card and Dietary EducationBehavioural
Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.
Usual CareOther
Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.
| Study group | Role | What they receive |
|---|---|---|
| Produce Gift Card to Usual Care | Experimental | Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months. Receives: Behavioral: Produce Gift Card and Dietary Education; Other: Usual Care |
| Usual Care to Produce Gift Card | Experimental | Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months. Receives: Behavioral: Produce Gift Card and Dietary Education; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c from Baseline to 5 Months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 5-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Hemoglobin A1c from Baseline to 10 Months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 10-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period
Measured: Baseline and 10 months
Secondary outcomes (30)
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 5 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 10 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Sitting Systolic Blood Pressure from Baseline to 5 Months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 5 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Sitting Systolic Blood Pressure from Baseline to 10 Months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 10 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Body Weight from Baseline to 5 Months
Change in body weight (kg), measured at baseline and at the 5 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Body Weight from Baseline to 10 Months
Change in body weight (kg), measured at baseline and at the 10 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Body Mass Index (BMI) from Baseline to 5 Months
Change in body mass index (kg/m²), measured at baseline and at the 5 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Body Mass Index (BMI) from Baseline to 10 Months
Change in body mass index (kg/m²), measured at baseline and at the 10 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Waist Circumference from Baseline to 5 Months
Change in waist circumference (cm), measured at baseline and at the 5 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Waist Circumference from Baseline to 10 Months
Change in waist circumference (cm), measured at baseline and at the 10 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months
Change in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months
hange in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Healthy Eating Index (HEI) Score from Baseline to 5 Months
The Healthy Eating Index (HEI) score will be measured at baseline and at 5 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Healthy Eating Index (HEI) Score from Baseline to 10 Months
The Healthy Eating Index (HEI) score will be measured at baseline and at 10 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Daily Fruit and Vegetable Intake from Baseline to 5 Months
Change in mean daily fruit and vegetable intake (cups/day) from baseline and 5 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Daily Fruit and Vegetable Intake from Baseline to 10 Months
Change in mean daily fruit and vegetable intake (cups/day) from baseline and 10 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Anxiety Score (HADS-A) from Baseline to 5 Months
Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Anxiety Score (HADS-A) from Baseline to 10 Months
Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Depression Score (HADS-D) from Baseline to 5 Months
Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Depression Score (HADS-D) from Baseline to 10 Months
Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Physical Activity (IPAQ) from Baseline to 5 Months
Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 5 month study visit. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Physical Activity (IPAQ) from Baseline to 10 Months
Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 10 month study visit. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Total Cholesterol from Baseline to 5 Months
Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Total Cholesterol from Baseline to 10 Months
Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 5 Months
Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Low-Density Lipoprotein (LDL) Cholesterol Baseline to 10 months
Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 5 Months
Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in High-Density Lipoprotein (HDL) Cholesterol Baseline to 10 months
Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Change in Triglycerides from Baseline to 5 Months
Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 5 months
Change in Triglycerides Baseline to 10 months
Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Measured: Baseline and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- Crossover
- Model description
- This is a randomized crossover study in which participants are assigned to one of two sequences: a produce prescription intervention consisting of fruit and vegetable vouchers plus standardized dietary education for 5 months followed by usual care for 5 months, or usual care for 5 months followed by the produce prescription intervention for 5 months. Outcomes are assessed at baseline, 5 months, and 10 months. Analyses compare outcomes during intervention and usual care periods while accounting for treatment sequence and study period.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Sokos, West Virginia University
- Investigators
- George Sokos, DO, FACC, Principal investigator, West Virginia University Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674979
- Sponsor's protocol ID
- STUDY00000327
- Acronym
- GARDEN-CARDIO
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, prospectively collected data points (lab values, vital signs, survey results) will be shared. All shared data will be completely anonymous.
Publications
Panizza CE, Shvetsov YB, Harmon BE, Wilkens LR, Le Marchand L, Haiman C, Reedy J, Boushey CJ. Testing the Predictive Validity of the Healthy Eating Index-2015 in the Multiethnic Cohort: Is the Score Associated with a Reduced Risk of All-Cause and Cause-Specific Mortality? Nutrients. 2018 Apr 5;10(4):452. doi: 10.3390/nu10040452.
PubMed 29621192Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Seligman HK, Angell SY, Berkowitz SA, Elkind MSV, Hager K, Moise N, Posner H, Muse J, Odoms-Young A, Ridberg R, Troxel AB, Yaroch AL, Volpp KG. A Systematic Review of "Food Is Medicine" Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association. Circulation. 2025 Jul 29;152(4):e32-e46. doi: 10.1161/CIR.0000000000001343. Epub 2025 Jun 18.
PubMed 40528749Mozaffarian D, Aspry KE, Garfield K, Kris-Etherton P, Seligman H, Velarde GP, Williams K, Yang E; ACC Prevention of Cardiovascular Disease Section Nutrition and Lifestyle Working Group and Disparities of Care Working Group. "Food Is Medicine" Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Feb 27;83(8):843-864. doi: 10.1016/j.jacc.2023.12.023.
PubMed 38383100
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity
- ClinicalTrials.gov ID
- NCT07674979
- Acronym / sponsor ID
- GARDEN-CARDIO / STUDY00000327
- Conditions
- Type 2 Diabetes
- Keywords
- Food Insecurity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Jun 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.
This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized crossover study in which participants are assigned to one of two sequences: a produce prescription intervention consisting of fruit and vegetable vouchers plus standardized dietary education for 5 months followed by usual care for 5 months, or usual care for 5 months followed by the produce prescription intervention for 5 months. Outcomes are assessed at baseline, 5 months, and 10 months. Analyses compare outcomes during intervention and usual care periods while accounting for treatment sequence and study period.
| Arm | Type | Receives |
|---|---|---|
| Produce Gift Card to Usual Care | Experimental | Behavioral: Produce Gift Card and Dietary Education, Other: Usual CareParticipants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months. |
| Usual Care to Produce Gift Card | Experimental | Behavioral: Produce Gift Card and Dietary Education, Other: Usual CareParticipants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 diabetes mellitus
- Most recent HbA1c >8% within the prior 6 months
- Must have had a clinic visit within the past 6 months
- Positive screening for food insecurity based on the USDA 6-item food security survey
- Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics
Key exclusion criteria (7 listed)
- End-stage renal disease
- Advanced heart failure
- Severe cognitive impairment
- Chronic pancreatitis
- Pancreatic malignancy
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 |
|---|---|---|
| Produce Gift Card and Dietary EducationParticipants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only. | Behavioural | Produce Gift Card to Usual Care, Usual Care to Produce Gift Card |
| Usual CareParticipants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period. | Other | Produce Gift Card to Usual Care, Usual Care to Produce Gift Card |
Primary outcome
Change in Hemoglobin A1c from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 5-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Change in Hemoglobin A1c from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 10-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period
30 secondary outcomes
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Sitting Systolic Blood Pressure from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Sitting Systolic Blood Pressure from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Body Weight from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Body Weight from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Body Mass Index (BMI) from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Body Mass Index (BMI) from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Waist Circumference from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Waist Circumference from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Healthy Eating Index (HEI) Score from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Healthy Eating Index (HEI) Score from Baseline to 10 Months
Time frame: Baseline and 10 months
Daily Fruit and Vegetable Intake from Baseline to 5 Months
Time frame: Baseline and 5 months
Daily Fruit and Vegetable Intake from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Anxiety Score (HADS-A) from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Anxiety Score (HADS-A) from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Depression Score (HADS-D) from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Depression Score (HADS-D) from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Physical Activity (IPAQ) from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Physical Activity (IPAQ) from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Total Cholesterol from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Total Cholesterol from Baseline to 10 Months
Time frame: Baseline and 10 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Low-Density Lipoprotein (LDL) Cholesterol Baseline to 10 months
Time frame: Baseline and 10 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in High-Density Lipoprotein (HDL) Cholesterol Baseline to 10 months
Time frame: Baseline and 10 months
Change in Triglycerides from Baseline to 5 Months
Time frame: Baseline and 5 months
Change in Triglycerides Baseline to 10 months
Time frame: Baseline and 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 29621192Panizza CE, Shvetsov YB, Harmon BE, Wilkens LR, Le Marchand L, Haiman C, Reedy J, Boushey CJ. Testing the Predictive Validity of the Healthy Eating Index-2015 in the Multiethnic Cohort: Is the Score Associated with a Reduced Risk of All-Cause and Cause-Specific Mortality? Nutrients. 2018 Apr 5;10(4):452. doi: 10.3390/nu10040452.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 40528749Seligman HK, Angell SY, Berkowitz SA, Elkind MSV, Hager K, Moise N, Posner H, Muse J, Odoms-Young A, Ridberg R, Troxel AB, Yaroch AL, Volpp KG. A Systematic Review of "Food Is Medicine" Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association. Circulation. 2025 Jul 29;152(4):e32-e46. doi: 10.1161/CIR.0000000000001343. Epub 2025 Jun 18.
- Background: PubMed 38383100Mozaffarian D, Aspry KE, Garfield K, Kris-Etherton P, Seligman H, Velarde GP, Williams K, Yang E; ACC Prevention of Cardiovascular Disease Section Nutrition and Lifestyle Working Group and Disparities of Care Working Group. "Food Is Medicine" Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Feb 27;83(8):843-864. doi: 10.1016/j.jacc.2023.12.023.
- USDA 6-item food insecurity surveyLink provided by the sponsor.
- International Physical Activity Questionnaire scoringLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon reasonable request, prospectively collected data points (lab values, vital signs, survey results) will be shared. All shared data will be completely anonymous.
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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.
George Sokos, DO, FACC principal investigator
West Virginia University Heart and Vascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Gift Card and Dietary Education in people with Type 2 Diabetes, run by West Virginia 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 17 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?
This study is still under way. Results are not available in the source record yet.
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 Hemoglobin A1c from Baseline to 5 Months (time frame: Baseline and 5 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 NCT07674979, which also lists 4 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 17 Aug 2026.