NCT06107816 · Milton S. Hershey Medical Center
A Fruit and Vegetable Prescription Program
What this study is about
Dietary intake of fruits and vegetables (F\&V) is a cornerstone for the treatment of type 2 diabetes, however less than 16% of Hispanic adults consume the recommended number of servings each day. F\&V prescription (F\&V Rx) programs are embedded into clinical settings and provide patients with vouchers to purchase F\&V at local retailers.
View original scientific description
Dietary intake of fruits and vegetables (F\&V) is a cornerstone for the treatment of type 2 diabetes, however less than 16% of Hispanic adults consume the recommended number of servings each day. F\&V prescription (F\&V Rx) programs are embedded into clinical settings and provide patients with vouchers to purchase F\&V at local retailers. The proposed study aims to test the effects of a F\&V Rx on diabetes self-management education and support (DSME/S) uptake and retention, dietary intake of F\&V and diet quality, glucose control (hemoglobin A1c), and program implementation outcomes.
Interventions
BEHAVIORAL
Usual Care
Visit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions
BEHAVIORAL
F&V Rx alone
Usual Care plus four F\&V prescriptions that are independent of DSME/S attendance
BEHAVIORAL
F&V Rx plus DSME/S
Usual Care plus four F\&V prescriptions that are dependent on DSME/S attendance
Primary outcome measures
Evaluate the impact of a F&V Rx on DSME/S uptake in low-income adults
Time frame: Throughout the 16 week intervention
Defined as the number of participants who attend any 1 DSME (# attend any 1 DSME/S session/total # randomized)
Evaluate the impact of a F&V Rx on DSME/S retention in low-income adults.
Time frame: Throughout the 16 week intervention
Defined as % who attend \>=75% of sessions (# attend \>= 75% sessions/ # attended any 1 DSME/S session)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient at Penn State Health St. Joe's Medical Center
- Diagnosis of Type 2 Diabetes Mellitus greater than or equal to six months
- A1c level is greater than or equal to 7% (53 mmol/mol)
- Low income defined as enrolled in Supplemental Nutrition Assistance Program (SNAP), is uninsured or have Medicaid, or identifying as food insecure based on USDA criteria.
- Ability to give a blood sample
- Willing to respond to contacts from study staff over the study period
- Willing and able to give informed consent
- Can read and write in English or Spanish
Exclusion criteria
- Diagnosis of Type 2 Diabetes Mellitus less than six months
- Patients who have previously participated in the Veggie Rx program in the past year
- Patients who have attended any diabetes self-management education and support (DSME/S) sessions in the past year
- Women who are pregnant or who plan to become pregnant during the study period
- Any uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past six months
- Any unstable or significant medical condition in the past 3 months (e.g. recent heart attack, stroke, DVT)
- A1c level is less than 7%
- Does not speak English or Spanish
- Inability to provide informed consent
- Unable to give a blood sample
Where
- Reading, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations