A Fruit and Vegetable Prescription Program

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107816
• Other study ID #: 23681
• Secondary ID: R01DK132077-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Milton S. Hershey Medical Center
• Contact: Susan Veldheer, DEd, RD
• Phone: 717-531-5625
• Email: sveldheer[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Consuming a nutrient-dense diet, rich in fruits and vegetables (F&Vs) is at the cornerstone of type 2 diabetes (T2DM) treatment. Yet, among Hispanic adults, only 16% meet the recommended minimum F&V intake recommendations and have higher rates of T2DM than non-Hispanic whites (16.6% versus 13.3%, respectively). F&V Prescription (F&V Rx) programs are embedded in clinical settings, target medically high-risk patients such as those with T2DM, and provide them with vouchers to purchase F&V at local retailers. Preliminary F&V Rx studies in patients with T2DM have found F&V intake increases of 0.2-1.6 servings per day and hemoglobin A1c (A1c) reductions from 0.35-0.71% [3.8 -7.8 mmol/mol]. However, none of these studies included diabetes self-management education and support (DSME/S) which can lead to A1c decreases from 0.24% to 1.0% [2.6-10.9 mmol/mol]. The team conducted a pilot F&V Rx study where DSME/S attendance was incentivized by providing a F&V Rx at each session. Although DSME/S uptake is typically very low after referral (around 5-7%), the program had a 73% first session attendance rate. Further, at 7 months post-program, a clinically- and statistically-significant reduction was found in A1c of 1.3% [14.2 mmol/mol] (p=.001). Although the receipt of the F&V Rx vouchers was contingent upon DSME/S attendance in the study, other T2DM-focused F&V Rx studies did not have DSME/S attendance requirements and also saw A1c reductions. Thus, understanding the effect of a F&V Rx on DSME/S uptake and retention with and without attendance requirements is a key design issue that must be evaluated. This proposal is in response to PAS 20-160 for short-term, pilot randomized controlled trials (RCTs) to acquire preliminary data regarding trial design. The team proposes a 3-Arm, 16-week, pilot RCT (n=120) for low-income adults (aged 18+) with T2DM (A1c >7% [53 mmol/mol]). The control group (n=40) will receive usual care (UC). The two intervention groups (n=40 each) will receive UC plus a F&V Rx that is either independent of DSME/S attendance (F&V Rx alone) or dependent on DSME/S attendance (F&V Rx + DSME/S). First, the investigators will systematically explore the impact of a F&V Rx on uptake and retention in DSME/S. Next, the investigators will explore changes in A1c, and diet-related outcomes. Finally, with implementation in mind, the investigators will use Proctor's implementation taxonomy, and the cultural adaptation framework from Castro et al., to assess program appropriateness, acceptability, and sustainability with both participants and clinical care providers. The study team and the Community Advisory Board (CAB) have the research, clinical expertise, and established retail network necessary to conduct a F&V Rx trial in a low-income, Hispanic community. The findings of this trial will inform the design of a future, fully powered RCT and address gaps in knowledge related to how F&V Rx programs impact T2DM-related outcomes. If effective, F&V Rx programs have the potential to improve diabetes self-management and reduce the clinical burden of poor glycemic control, particularly in low-income, Hispanic communities.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus

Intervention

Behavioral:
• Usual Care
Visit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions
• F&V Rx alone
Usual Care plus four F&V prescriptions that are independent of DSME/S attendance
• F&V Rx plus DSME/S
Usual Care plus four F&V prescriptions that are dependent on DSME/S attendance

Locations

Country	Name	City	State
United States	Penn State Health St. Joseph Downtown Campus	Reading	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Throughout the 16 week intervention and follow-up
Other	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.	Throughout the 16 week intervention and follow-up
Other	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	Throughout the 16 week intervention and follow-up
Primary	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)	Throughout the 16 week intervention
Primary	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)	Throughout the 16 week intervention
Secondary	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.	Baseline (week 0) and follow up (week 16)
Secondary	Evaluate the impact of a F&V Rx on Diabetes Self-Management	Measured by DSME questionnaire	Baseline (week 0) and follow up (week 16)
Secondary	Evaluate the impact of a F&V Rx on Fruit and Vegetable Intake	Based on the 24-hour recalls	Baseline (week 0) and follow up (week 16)
Secondary	Evaluate the impact of a F&V Rx on Healthy Eating index-2015	Based on the 24-hour recalls	Baseline (week 0) and follow up (week 16)
Secondary	Evaluate the impact of a F&V Rx on Total plasma carotenoids (ng/mL)	Plasma carotenoids will be separated into the total and five individual concentrations (a-carotene, ß-carotene, lutein, lycopene, and cryptoxanthin) using high-performance liquid chromatography methodology using our Sciex Exion LC-Sciex QTRAP 6500+ mass spectrometry system.	Baseline (week 0) and follow up (week 16)
Secondary	Evaluate the impact of a F&V Rx on Food insecurity	Measured by the 18-item USDA Food Insecurity Questionnaire	Baseline (week 0) and follow up (week 16)