Status:

NOT_YET_RECRUITING

Community Pharmacy Produce Prescriptions

Lead Sponsor:

Tufts University

Collaborating Sponsors:

National Association of Chain Drug Stores

Conditions:

Diabetes Mellitus Type 2

Hypertension

Eligibility:

All Genders

18+ years

Phase:

NA

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/...

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 thes...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

610 Patients enrolled

Trial Details

Trial ID

NCT06920355

Start Date

April 1 2025

End Date

June 1 2026

Last Update

April 9 2025

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