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A Fruit and Vegetable Prescription Program

A Pilot, 3-arm Randomized Controlled Trial of a Fruit and Vegetable Prescription Program for Patients With Type Two Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a program that gives patients vouchers to buy fruits and vegetables at local stores. It will look at eating habits, blood sugar control, joining and staying in diabetes classes and support, and how the program works. It is for patients with low income and type 2 diabetes at Penn State Health St. Joe's Medical Center.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Get care at Penn State Health St. Joe's Medical Center.
  • Have had type 2 diabetes for at least 6 months.
  • Have an A1c of 7% or higher. A1c measures average blood sugar.
  • Meet the study's low-income rule: receive SNAP food benefits, have no health insurance, have Medicaid, or lack reliable access to enough food under USDA rules.
  • Can give a blood sample.
  • Are willing to respond to study staff during the study.
  • Are willing and able to give informed consent, meaning you understand the study and agree to join.
  • Can read and write in English or Spanish.

Who can't join

  • Have had type 2 diabetes for less than 6 months, or have an A1c below 7%.
  • Took part in the Veggie Rx program in the past year.
  • Attended any diabetes self-care classes or support sessions in the past year.
  • Are pregnant or plan to become pregnant during the study.
  • Have an uncontrolled mental illness or substance abuse problem, or had treatment in a hospital for either in the past 6 months.
  • Had an unstable or serious health condition in the past 3 months, such as a heart attack, stroke, or blood clot in a deep vein.
  • Do not speak English or Spanish.
  • Cannot give informed consent or a blood sample.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA