Dietary ModificationNCT02794818
Penn State ProduceRx Feasibility Study
An observational study of Dietary Modification, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Produce boxes with nutritional education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients determined to be "underserved" or "at-risk" within the Penn State Health System
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Penn State ProduceRx Feasibility Study: Developing a "Prescription Produce" Model That Can Impact Long-term Health Outcomes for Patients
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.
Read the detailed description
Participating prescribers within the Penn State Health system will identify potential patients for ProduceRx based on the "high-risk" or "underserved" requirements. For the initial pilot starting on August 1, 2016, the following four physicians have agreed to participate with the program/study: Dr. Ann Rogers, Dr. Marsha Novick, Dr. Peter Lewis, and Dr. Laurie Nelson, whose specialties are general surgery and minimally invasive bariatric surgery, adolescent and bariatric medicine, family medicine, and internal medicine, respectively. Additionally, Lisa Hardy, a nurse practitioner at Dr. Ann Rogers' bariatric clinic, and Christine Bruce, a physician assistant at Dr. Laurie Nelson's internal medicine clinic will serve as the fifth and sixth prescribers. Prescribers will be provided with ProduceRx prescription pads that they will use to write "prescriptions" for their patients to the program. The prescription pads will be coded with a unique identifying code at the bottom that will allow researchers to keep track of data associated with that prescription (i.e. patient compliance with the program, difference in patient outcomes with different providers, etc.).
Patients will be recruited by the abovementioned physicians based on the physicians' interpretation of the two qualifications for the program: "high-risk" or "underserved." Recruiting materials such as informational brochures and advertisement signs (both electronic and printed) will be utilized to help these providers explain the program to qualifying patients without sacrificing time in the office. If selected patients elect to participate in the program, they will visit the ProduceRx website at https://sites.psu.edu/producerx and register for the program. Initial registration will feature an informed consent form to participate in research associated with this program. Patients will have the option of consenting or declining to consent to participation in this research. For those that consent, they will complete their initial survey through REDCap before bring routed to the participating farm's weekly ordering platform. Those patients who decline to consent will be automatically routed to the participating farm's ordering platform to order their first weekly box.
The survey will be a modified version of the CDC's Behavioral Risk Factor Surveillance System Questionnaire (BRFSS). This survey will assess patients' demographic characteristics, as well as health characteristics and behaviors. Demographic variables include age, race/ethnicity, education level, and employment status. Health characteristics include self-reported medical conditions, and height and weight (for calculation of body mass index). The survey will ask participants to self-report fruit and vegetable consumption and perceived barriers to consumption. Level of physical activity will also be monitored throughout the program to see if it is affected by changes in nutrition. Additionally, investigators will measure compliance of patients with the program; compliance will be defined as the number of weeks that patients voluntarily participate (purchase weekly boxes of produce) throughout the program from the time that they register with the program until the end of the pilot in December 2016.
During subsequent weeks, patients will visit the farm's website directly to order their weekly produce boxes. Participants will be asked to complete a post-program questionnaire at the end of the pilot in December 2016. Meanwhile, the main ProduceRx website will function as a platform for nutritional education delivery (delivered by medical students, registered dietitians, dietetic interns, as well as opportunities for other healthcare workers and community members), with links to the program's YouTube cooking/nutrition videos and postings of electronic versions of the printed newsletters. The website will also feature a calendar of upcoming local events, such as nature hikes, outdoor walks, free cooking classes, and farmers' markets, in order to facilitate an overall healthy lifestyle outside of the actual program. Additionally, the website will feature a comments section for participants to ask questions and communicate with one another. This comments section will be monitored to ensure appropriate commenting.
At the end of the program, a focus group will be held at Penn State Hershey Medical Center (PSHMC) to evaluate the functionality/feasibility of the pilot, including logistical convenience, how much produce was utilized each week, and what challenges participants faced integrating the produce and educational content into their daily lives. The focus group will ideally last from 45 to 90 minutes and will be moderated by Sarayna Schock, an MSII and PI on this study. A semi-structured interview guide will be used and responses will be recorded to adequately capture all feedback. These focus group responses will be recorded and transcribed by research volunteers and analyzed by an interdisciplinary research team to identify emergent themes.
To ease the burden of time constraints already imposed on physicians, participating healthcare providers will be surveyed via email at the end of the pilot to evaluate their perceived program efficacy, the benefit of the program to their patients, and elicit program feedback. A semi-structured survey created with REDCap will be used to solicit specific responses, in addition to open feedback.
- Conditions
- Dietary Modification
- Being tested
- Produce boxes with nutritional education
- Keywords
- Prevention, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce boxes with nutritional educationBehavioural
CSA produce boxes "prescribed" to study participants with free online nutritional education included
| Study group | Role | What they receive |
|---|---|---|
| Participating Patients | Participating patients will receive a prescription for weekly CSA produce boxes with nutritional education Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified CDC BRFSS Survey
Questionnaire items will assess participants' demographic characteristics, health characteristics, and behaviors.
Measured: 18-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarayna Schock, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794818
- Sponsor's protocol ID
- STUDY00005088
- Status last verified
- Feb 2017
- First submitted
- 25 May 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24421001
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penn State ProduceRx Feasibility Study: Developing a "Prescription Produce" Model That Can Impact Long-term Health Outcomes for Patients
- ClinicalTrials.gov ID
- NCT02794818
- Acronym / sponsor ID
- STUDY00005088
- Conditions
- Dietary Modification
- Keywords
- Prevention, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participating prescribers within the Penn State Health system will identify potential patients for ProduceRx based on the "high-risk" or "underserved" requirements. For the initial pilot starting on August 1, 2016, the following four physicians have agreed to participate with the program/study: Dr. Ann Rogers, Dr. Marsha Novick, Dr. Peter Lewis, and Dr. Laurie Nelson, whose specialties are general surgery and minimally invasive bariatric surgery, adolescent and bariatric medicine, family medicine, and internal medicine, respectively. Additionally, Lisa Hardy, a nurse practitioner at Dr. Ann Rogers' bariatric clinic, and Christine Bruce, a physician assistant at Dr. Laurie Nelson's internal medicine clinic will serve as the fifth and sixth prescribers. Prescribers will be provided with ProduceRx prescription pads that they will use to write "prescriptions" for their patients to the program. The prescription pads will be coded with a unique identifying code at the bottom that will allow researchers to keep track of data associated with that prescription (i.e. patient compliance with the program, difference in patient outcomes with different providers, etc.).
Patients will be recruited by the abovementioned physicians based on the physicians' interpretation of the two qualifications for the program: "high-risk" or "underserved." Recruiting materials such as informational brochures and advertisement signs (both electronic and printed) will be utilized to help these providers explain the program to qualifying patients without sacrificing time in the office. If selected patients elect to participate in the program, they will visit the ProduceRx website at https://sites.psu.edu/producerx and register for the program. Initial registration will feature an informed consent form to participate in research associated with this program. Patients will have the option of consenting or declining to consent to participation in this research. For those that consent, they will complete their initial survey through REDCap before bring routed to the participating farm's weekly ordering platform. Those patients who decline to consent will be automatically routed to the participating farm's ordering platform to order their first weekly box.
The survey will be a modified version of the CDC's Behavioral Risk Factor Surveillance System Questionnaire (BRFSS). This survey will assess patients' demographic characteristics, as well as health characteristics and behaviors. Demographic variables include age, race/ethnicity, education level, and employment status. Health characteristics include self-reported medical conditions, and height and weight (for calculation of body mass index). The survey will ask participants to self-report fruit and vegetable consumption and perceived barriers to consumption. Level of physical activity will also be monitored throughout the program to see if it is affected by changes in nutrition. Additionally, investigators will measure compliance of patients with the program; compliance will be defined as the number of weeks that patients voluntarily participate (purchase weekly boxes of produce) throughout the program from the time that they register with the program until the end of the pilot in December 2016.
During subsequent weeks, patients will visit the farm's website directly to order their weekly produce boxes. Participants will be asked to complete a post-program questionnaire at the end of the pilot in December 2016. Meanwhile, the main ProduceRx website will function as a platform for nutritional education delivery (delivered by medical students, registered dietitians, dietetic interns, as well as opportunities for other healthcare workers and community members), with links to the program's YouTube cooking/nutrition videos and postings of electronic versions of the printed newsletters. The website will also feature a calendar of upcoming local events, such as nature hikes, outdoor walks, free cooking classes, and farmers' markets, in order to facilitate an overall healthy lifestyle outside of the actual program. Additionally, the website will feature a comments section for participants to ask questions and communicate with one another. This comments section will be monitored to ensure appropriate commenting.
At the end of the program, a focus group will be held at Penn State Hershey Medical Center (PSHMC) to evaluate the functionality/feasibility of the pilot, including logistical convenience, how much produce was utilized each week, and what challenges participants faced integrating the produce and educational content into their daily lives. The focus group will ideally last from 45 to 90 minutes and will be moderated by Sarayna Schock, an MSII and PI on this study. A semi-structured interview guide will be used and responses will be recorded to adequately capture all feedback. These focus group responses will be recorded and transcribed by research volunteers and analyzed by an interdisciplinary research team to identify emergent themes.
To ease the burden of time constraints already imposed on physicians, participating healthcare providers will be surveyed via email at the end of the pilot to evaluate their perceived program efficacy, the benefit of the program to their patients, and elicit program feedback. A semi-structured survey created with REDCap will be used to solicit specific responses, in addition to open feedback.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participating Patients | – | Behavioral: Produce boxes with nutritional educationParticipating patients will receive a prescription for weekly CSA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients determined to be "underserved" or "at-risk" within the Penn State Health System
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce boxes with nutritional educationCSA produce boxes "prescribed" to study participants with free online nutritional education included | Behavioural | Participating Patients |
Primary outcome
Modified CDC BRFSS Survey
Time frame: 18-week study period
Questionnaire items will assess participants' demographic characteristics, health characteristics, and behaviors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Background: PubMed 24421001Kraschnewski 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.
- Main ProduceRx program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Modification, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified CDC BRFSS Survey (time frame: 18-week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.