RECRUITING

A Fruit and Vegetable Prescription Program

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-26
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06107816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient at Penn State Health St. Joe's Medical Center
  2. * Diagnosis of Type 2 Diabetes Mellitus greater than or equal to six months
  3. * A1c level is greater than or equal to 7% (53 mmol/mol)
  4. * 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.
  5. * Ability to give a blood sample
  6. * Willing to respond to contacts from study staff over the study period
  7. * Willing and able to give informed consent
  8. * Can read and write in English or Spanish
  1. * Diagnosis of Type 2 Diabetes Mellitus less than six months
  2. * Patients who have previously participated in the Veggie Rx program in the past year
  3. * Patients who have attended any diabetes self-management education and support (DSME/S) sessions in the past year
  4. * Women who are pregnant or who plan to become pregnant during the study period
  5. * Any uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past six months
  6. * Any unstable or significant medical condition in the past 3 months (e.g. recent heart attack, stroke, DVT)
  7. * A1c level is less than 7%
  8. * Does not speak English or Spanish
  9. * Inability to provide informed consent
  10. * Unable to give a blood sample

Contacts and Locations

Study Contact

Susan Veldheer, DEd, RD
CONTACT
717-531-5625
sveldheer@pennstatehealth.psu.edu
Kayla N Rutt, MS
CONTACT
717-858-6204
krutt1@pennstatehealth.psu.edu

Principal Investigator

Susan Veldheer, DEd, RD
PRINCIPAL_INVESTIGATOR
Penn State College of Medicine

Study Locations (Sites)

Penn State Health St. Joseph Downtown Campus
Reading, Pennsylvania, 19601
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Susan Veldheer, DEd, RD, PRINCIPAL_INVESTIGATOR, Penn State College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2027-06

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Diabetes Complications