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Active Not Recruiting
NCT06920355
Community Pharmacy Produce Prescriptions
Conditions: Diabetes Mellitus Type 2, Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 610
Sponsor: Tufts University
Location: Walmart Bentonville Arkansas
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.
Eligibility Criteria
Inclusion Criteria:
* 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:
1. Hunger Vital Sign™ screening and,
2. Nutrition Security Screener
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06920355). StuddyBuddy aggregates publicly available trial information.