Penn State Hershey Sitting and Health Study

• ClinicalTrials.gov Identifier: NCT03274635
• Recruitment Status: Completed
• First Posted: September 7, 2017
• Last Update Posted: October 19, 2020
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Liza Rovniak, Milton S. Hershey Medical Center

Tracking Information

• First Submitted Date: September 1, 2017
• First Posted Date: September 7, 2017
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: June 12, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Penn State Hershey Sitting and Health Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Physical Activity

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 5, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 11, 2020
• Actual Primary Completion Date: June 12, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03274635
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Liza Rovniak, Milton S. Hershey Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Milton S. Hershey Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Milton S. Hershey Medical Center
• Verification Date: October 2020