Community Pharmacy Produce Prescriptions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTufts University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Produce Prescription
Other interventionEach 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.
Nutrition Education
BehavioralParticipating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.
Treatment groups
610 Participants
are divided into 1 treatment groupGroup A: Produce Prescription GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 6-months2
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.
Time frame
Up to 6-months3
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.
Time frame
baseline, 3-months, 6-months4
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."
Time frame
baseline, 3-months, 6-monthsSecondary outcomes
1
Change in Hemoglobin A1c
For participants with diabetes, pharmacy staff will conduct a point-of-care hemoglobin A1c measurement of blood obtained by fingerstick.
Time frame
baseline and 6-months2
Change in Continuous Glucose Monitor (CGM) Time-in-range
Time-in-range is the percentage of time spent with glucose levels in the target range. For participants with diabetes, pharmacy staff place a CGM, per product instructions, on the participant with a goal to wear for 10 days (each time).
Time frame
baseline and 6-months3
Change in Blood Pressure
Pharmacy staff will measure participants' systolic and diastolic blood pressure.
Time frame
baseline and 6-months4
Change in Body Mass Index
Pharmacy staff will collect height and weight.
Time frame
baseline and 6-monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts University
Lead sponsor
National Association of Chain Drug Stores
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: