A Fruit and Vegetable Prescription Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Usual Care
BehavioralVisit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions
F&V Rx alone
BehavioralUsual Care plus four F\&V prescriptions that are independent of DSME/S attendance
F&V Rx plus DSME/S
BehavioralUsual Care plus four F\&V prescriptions that are dependent on DSME/S attendance
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Usual Care Control GroupPlacebo comparator 1 intervention
Group B: F&V Rx Alone GroupActive comparator 1 intervention
Group C: F&V Rx + DSME/S GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the impact of a F&V Rx on DSME/S uptake in low-income adults
Defined as the number of participants who attend any 1 DSME (# attend any 1 DSME/S session/total # randomized)
Time frame
Throughout the 16 week intervention2
Evaluate the impact of a F&V Rx on DSME/S retention in low-income adults.
Defined as % who attend \>=75% of sessions (# attend \>= 75% sessions/ # attended any 1 DSME/S session)
Time frame
Throughout the 16 week interventionSecondary outcomes
1
Evaluate the impact of a F&V Rx on A1c (% and mg/dL)
Blood biomarker assessment will be taken and analyzed by the Penn State Health Clinical Labs.
Time frame
Baseline (week 0) and follow up (week 16)2
Evaluate the impact of a F&V Rx on Diabetes Self-Management
Measured by DSME questionnaire
Time frame
Baseline (week 0) and follow up (week 16)3
Evaluate the impact of a F&V Rx on Fruit and Vegetable Intake
Based on the 24-hour recalls
Time frame
Baseline (week 0) and follow up (week 16)4
Evaluate the impact of a F&V Rx on Healthy Eating index-2015
Based on the 24-hour recalls
Time frame
Baseline (week 0) and follow up (week 16)Other outcomes
1
Assess program implementation outcomes - Acceptability of Intervention Measure (AIM)
A four-item measure implementation outcomes to assess acceptability of the DSME/S sessions and the overall intervention for participants.
Time frame
Throughout the 16 week intervention and follow-up2
Assess program implementation outcomes - Intervention Appropriateness Measure (IAM)
A four-item measure of implementation to assess the appropriateness of the DSME/S sessions and the overall intervention for participants.
Time frame
Throughout the 16 week intervention and follow-up3
Assess program implementation outcomes - Clinic/providers/staff - Implementation Outcomes Questionnaire (IOQ)
Survey that measures implementation success of the intervention from the perspective of stakeholders who carry out the daily operations
Time frame
Throughout the 16 week intervention and follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov