NCT02794818

Brief Summary

To provide "prescriptions" for weekly Community Supported Agriculture (CSA) boxes of fruits and vegetables to patients, accompanied by nutritional education (e.g. printed newsletters and YouTube videos), and evaluate benefits for participants by exploring commitment to the program, opinions about healthy eating, retention of nutrition and food preparation knowledge, overall takeaway from the program, as well as self-assessment of health status. To establish the overall feasibility of an effective "prescription produce" program for at-risk and underserved patients - called "ProduceRx" - by utilizing produce from regional farms in addition to the resources of the Penn State Health System and an interdisciplinary team of healthcare workers (dietitians, dietetic interns, and medical students). To provide a proof-of-concept for this model (i.e. ProduceRx + interdisciplinary approach to health education) for other healthcare institutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

May 25, 2016

Last Update Submit

February 17, 2017

Conditions

Keywords

PreventionNutrition

Outcome Measures

Primary Outcomes (1)

  • Modified CDC BRFSS Survey

    Questionnaire items will assess participants' demographic characteristics, health characteristics, and behaviors.

    18-week study period

Study Arms (2)

Participating Patients

Participating patients will receive a prescription for weekly CSA produce boxes with nutritional education

Behavioral: Produce boxes with nutritional education

Participating Providers

Participating providers will be surveyed at the end of the pilot to evaluate their perceived program efficacy, the benefit of the program to their patients, and elicit program feedback.

Interventions

CSA produce boxes "prescribed" to study participants with free online nutritional education included

Participating Patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients determined to be "underserved" or "at-risk" within the Penn State Health System

You may qualify if:

  • Individuals (ages 18-75) who are currently patients in the Penn State Hershey Health system in the departments of Family and Community Medicine, General Pediatrics, Internal Medicine, General Surgery and Minimally Invasive Surgery/Bariatric, Endocrinology, and Cardiology.
  • Individuals at risk for developing chronic illness and metabolic disease as identified by PCP, care coordinator, or a participating physician from an abovementioned specialty.
  • Individuals willing to participate in the program and complete a pre-program survey and a post-program survey in December 2016.
  • Individuals with access to transportation to and from the CSA drop-off sites.
  • Individuals willing/able to pay the $10 subsidized "copay" for the weekly box of produce (federal food stamps in the form of SNAP/EBT vouchers will be accepted by Strites Orchard as a means of payment).
  • Individuals that speak English.
  • Individuals with difficulty obtaining fresh produce or lack of knowledge regarding healthy cooking methods and nutrition, as determined by PCP or a participating physician from an abovementioned specialty.
  • Prescribers (physicians, nurse practitioners, and physician assistants) in the Penn State Hershey Health system in the departments of Family and Community Medicine, General Pediatrics, Internal Medicine, General Surgery and Minimally Invasive Surgery/Bariatric, Endocrinology, and Cardiology.

You may not qualify if:

  • Individuals outside of immediate areas of Strites Orchard's CSA drop-off sites (which include the following: Bosler Avenue, Lemoyne; Koch Lane Harrisburg (Paxtonia); Allendale, Camp Hill; Strites Orchard, Harrisburg; Dogwood Lane, Dillsburg; East Willow Street, Elizabethtown; Hampden Summit; Linglestown Rd., Harrisburg; St. Johns Drive, Camp Hill; Shetland Dr., Hummelstown; West Areba Ave., Hershey; Wickerberry Lane, Palmyra; W. Green St., Mechanicsburg; Brisban St. Harrisburg (Paxtang); Cattell St., Middletown; and N. 2nd St., Harrisburg.)
  • Individuals unaffiliated with the Penn State Hershey Health System.
  • Individuals who already have sufficient fruits and vegetables in their diet as determined by the participating physician.
  • Non-English speaking participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Kraschnewski JL, George DR, Rovniak LS, Monroe DL, Fiordalis E, Bates E. Characterizing customers at medical center farmers' markets. J Community Health. 2014 Aug;39(4):727-31. doi: 10.1007/s10900-014-9818-x.

    PMID: 24421001BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSII

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 9, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations