NCT06920355

Community Pharmacy Produce Prescriptions

Community Pharmacy Produce Prescriptions (CP3): Design, Implementation, and Evaluation of a Produce Prescription Program in Community Pharmacies

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes. Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.

Detailed description

Produce prescription programs are an increasingly common Food is Medicine (FIM) intervention, with over 100 programs launched in US healthcare systems over the past decade. Mounting evidence from these programs suggests health-related benefits, including reductions in household food insecurity, increased consumption of fruits and vegetables, and improvements in clinical outcomes such as diastolic blood pressure, hemoglobin A1c, and body mass index. Pharmacies routinely engage in vital screening and referral services, including monitoring blood glucose, blood pressure, cholesterol levels, and administering vaccinations, among other patient care services. However, the community pharmacy setting has remained a largely underutilized and understudied platform for advancing FIM. Historically, FIM interventions have been designed and delivered through hospitals, medical clinics, or community non-profit organizations. The next phase of FIM efforts involves expanding screening and referral for such programs to community pharmacies, including those affiliated or co-located with grocery stores. Community Pharmacy Produce Prescriptions study intervention will be delivered via a Produce Prescription (PRx) electronic benefit card. Each month, participants will receive a fixed amount of funds on the PRx card to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.

Conditions

• Diabetes Mellitus Type 2
• Hypertension

Interventions

Type	Name	Description
OTHER	Produce Prescription	Each month, participants will receive a fixed amount of funds on the PRx card. Participants will be able to use these funds to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided through an electronic PRx benefit card that is activated after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
BEHAVIORAL	Nutrition Education	Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2025-04-09
• Last updated: 2025-04-09