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Penn State Hershey Sitting and Health 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: NCT03274635
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Liza Rovniak, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 7, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE October 16, 2017
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Change in Worker Productivity [ Time Frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends) ]
    Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.
  • Elliptical Device Pedaling Quantity [ Time Frame: 1 month (4 weeks) during pedaling program ]
    Objectively-measured pedaling quantity from elliptical device
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • Change in Worker Productivity [ Time Frame: Baseline (week immediately prior to program start) and post-program (week immediately after program ends) ]
    Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.
  • Elliptical Device Pedaling Quantity [ Time Frame: Ongoing, during 1 month (4-week) program/intervention phase ]
    Objectively-measured pedaling quantity from elliptical device
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • User satisfaction, process evaluations [ Time Frame: Post-program (immediately after program ends) ]
    Satisfaction with intervention condition
  • General (non-desk pedaling) physical activity [ Time Frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends) ]
    Self-reported physical activity
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
User satisfaction, process evaluations [ Time Frame: Post-program (week immediately after program ends) ]
Satisfaction with intervention condition
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Penn State Hershey Sitting and Health Study
Official Title  ICMJE Desk-Compatible Elliptical Device: Feasibility Evaluation
Brief Summary The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help employees to increase their daily physical activity without compromising work productivity; and (b) evaluate the effects of different types of incentives for pedaling the desk-based elliptical device on employees' pedaling quantity over a one-month intervention period. The study will involve placing a compact elliptical device (provided at no cost by the research team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data evaluating the effects of the elliptical device on work productivity will be obtained from both employees and the employees' supervisors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Physical Activity
Intervention  ICMJE Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Study Arms  ICMJE
  • Active Comparator: Usual Delayed Compensation, Money
    Will receive delayed monetary compensation with Amazon gift card, non performance-contingent.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
  • Active Comparator: Usual Delayed Compensation, Food
    Will receive delayed compensation with food-based gift card, non performance-contingent.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
  • Experimental: Individual Immediate Contingent Reward, Money
    Will receive daily performance-contingent monetary compensation with Amazon gift card.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
  • Experimental: Individual Immediate Contingent Reward, Food
    Will receive daily performance-contingent food-based gift card.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
  • Experimental: Joint Immediate Contingent Reward, Money
    Will receive daily performance-contingent monetary compensation with Amazon gift card, with additional compensation contingent on pedaling activity of co-worker participant.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
  • Experimental: Joint Immediate Contingent Reward, Food
    Will receive daily performance-contingent monetary compensation with food gift card, with additional compensation contingent on pedaling activity of co-worker participant.
    Intervention: Behavioral: Desk-based pedaling device and pedaling incentives provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 11, 2020
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Full time employee, employed at least 35 hours per week at Penn State Hershey
  • Able to provide documented approval from supervisor to participate
  • Age 18-70 years
  • Overweight or obese (BMI between 25-55)
  • Sit at desk at least 5 hours per day
  • Have regular working hours between 6 am and 6 pm on weekdays
  • Ability to understand written and spoken English
  • Own a smartphone (Android or iPhone) with Internet access
  • Willing to download cycling app on smartphone during one month study period

Exclusion Criteria:

  • Not present in Penn State Hershey office during study period due to personal circumstances such as travel/extended vacation or leave, relocation, or health-related circumstances
  • Advised to only do physical activity recommended by a physician
  • Chest pain during physical activity or during prior month
  • Currently has a desk-based pedaling device or treadmill workstation already installed at desk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274635
Other Study ID Numbers  ICMJE 1R21HL118453( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Liza Rovniak, Milton S. Hershey Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Milton S. Hershey Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP