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Penn State ProduceRx Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794818
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sarayna Schock, Milton S. Hershey Medical Center

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.


Condition or disease Intervention/treatment
Dietary Modification Behavioral: Produce boxes with nutritional education

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Penn State ProduceRx Feasibility Study: Developing a "Prescription Produce" Model That Can Impact Long-term Health Outcomes for Patients
Study Start Date : August 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
Participating Patients
Participating patients will receive a prescription for weekly CSA produce boxes with nutritional education
Behavioral: Produce boxes with nutritional education
CSA produce boxes "prescribed" to study participants with free online nutritional education included

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.



Primary Outcome Measures :
  1. Modified CDC BRFSS Survey [ Time Frame: 18-week study period ]
    Questionnaire items will assess participants' demographic characteristics, health characteristics, and behaviors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients determined to be "underserved" or "at-risk" within the Penn State Health System
Criteria

Inclusion Criteria:

  1. 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.
  2. Individuals at risk for developing chronic illness and metabolic disease as identified by PCP, care coordinator, or a participating physician from an abovementioned specialty.
  3. Individuals willing to participate in the program and complete a pre-program survey and a post-program survey in December 2016.
  4. Individuals with access to transportation to and from the CSA drop-off sites.
  5. 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).
  6. Individuals that speak English.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. 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.)
  2. Individuals unaffiliated with the Penn State Hershey Health System.
  3. Individuals who already have sufficient fruits and vegetables in their diet as determined by the participating physician.
  4. Non-English speaking participants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794818


Locations
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United States, Pennsylvania
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Additional Information:
Publications:
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Responsible Party: Sarayna Schock, MSII, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02794818    
Other Study ID Numbers: STUDY00005088
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sarayna Schock, Milton S. Hershey Medical Center:
Prevention
Nutrition