Community Pharmacy Produce Prescriptions

NCT06920355 | Not Yet Recruiting

• 1 other identifier: STUDY00005176
• Study Type: interventional
• Target: 610
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus Type 2; Hypertension

Keywords

Food is Medicine; Produce Prescriptions; Produce Rx; Community Pharmacy; Nutrition Security; Food Security; Nutrition Intervention; Food as Medicine

Outcome Measures

Primary Outcomes (5)

• Rate of PRx Program Utilization

  The utilization rate will be calculated by dividing the number of PRx cards redeemed by the total number of PRx cards distributed at each pharmacy.

  Up to 6-months

• Rate of PRx Program Redemption

  The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed.

  Up to 6-months

• Change in Food Security

  Assessed by the USDA's Household Food Security Survey Module: Six-Item Short Form. The sum of affirmative responses to the six questions is the household's raw score. A raw score of 0-1 indicates food security, while a score of 2-6 indicates food insecurity.

  baseline, 3-months, 6-months

• Change in Nutrition Security

  Assessed by the Nutrition Security Screener. Respondents will be classified as nutrition secure if they answer, "Not hard at all" or "Not very hard" to item 1 or nutrition insecure if they answer, "Somewhat hard", "Hard", or "Very Hard."

  baseline, 3-months, 6-months

• Change in Diet Quality

  Assessed by a modified Mini-Eating Assessment Tool (EAT). A calculated score will be created such that a higher score is indicative of healthier dietary patterns.

  baseline, 3-months, 6-months

Secondary Outcomes (6)

• Change in Hemoglobin A1c

  baseline and 6-months

• Change in Continuous Glucose Monitor (CGM) Time-in-range

  baseline and 6-months

• Change in Blood Pressure

  baseline and 6-months

• Change in Body Mass Index

  baseline and 6-months

• Change in Patient Reported Health Related Quality of Life

  baseline, 3-months, 6-months

Study Arms (1)

Produce Prescription Group

EXPERIMENTAL

Other: Produce Prescription; Behavioral: Nutrition Education

Interventions

Produce Prescription OTHER

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.

Also known as: Produce Rx

Produce Prescription Group

Nutrition Education BEHAVIORAL

Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.

Produce Prescription Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Age 18 years or older
• Presence of one or more of the following conditions: type 2 diabetes or hypertension. (Type 2 diabetes and hypertension will be defined by the combination of a self-reported physician diagnosis of one of the conditions and at least one pharmacy prescription for one of the conditions.)
• Able to converse, and complete the research surveys in English or Spanish, based on self-report.
• Positive screening for food or nutrition insecurity by:
• Hunger Vital Sign™ screening and,
• Nutrition Security Screener

You may not qualify if:

• Unable to provide informed consent.
• Unable to read and write.
• Self-reported serious medical conditions that may be expected to shorten life expectancy to less than one year
• A condition that limits participant's ability to grocery shop or choose food for themselves
• Plans to move to a new home in the next 6 months that would require use of a different pharmacy
• Currently pregnant or pregnancy planned within the next 6 months
• Currently using or planning to start an insulin pump or other automated insulin delivery device within the next 6 months
• Currently on a GLP-1 agonist or planning to start a GLP-1 agonist within the next 6 months
• Currently receiving or planning to receive within the next 6 months another Food is Medicine program, like PRx, Grocery Rx, or Medically Tailored Meals

Sponsors & Collaborators

• Tufts University: lead
• National Association of Chain Drug Stores: collaborator

Related Links

• Study Information Website
• Eligibility Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dariush Mozaffarian, MD, DrPH

  The Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary K Cohen, MS, RD

CONTACT

6176363942; mary_kathryn.cohen@tufts.edu

Patricia R Sheehan, RN, MPH, MS

CONTACT

Patricia_Ryan.Sheehan@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Food is Medicine Institute

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share