<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274635</url>
  </required_header>
  <id_info>
    <org_study_id>1R21HL118453</org_study_id>
    <nct_id>NCT03274635</nct_id>
  </id_info>
  <brief_title>Penn State Hershey Sitting and Health Study</brief_title>
  <official_title>Desk-Compatible Elliptical Device: Feasibility Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help&#xD;
      employees to increase their daily physical activity without compromising work productivity;&#xD;
      and (b) evaluate the effects of different types of incentives for pedaling the desk-based&#xD;
      elliptical device on employees' pedaling quantity over a one-month intervention period. The&#xD;
      study will involve placing a compact elliptical device (provided at no cost by the research&#xD;
      team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data&#xD;
      evaluating the effects of the elliptical device on work productivity will be obtained from&#xD;
      both employees and the employees' supervisors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Worker Productivity</measure>
    <time_frame>Baseline (1 month period prior to program start) and post-program (immediately after program ends)</time_frame>
    <description>Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elliptical Device Pedaling Quantity</measure>
    <time_frame>1 month (4 weeks) during pedaling program</time_frame>
    <description>Objectively-measured pedaling quantity from elliptical device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>User satisfaction, process evaluations</measure>
    <time_frame>Post-program (immediately after program ends)</time_frame>
    <description>Satisfaction with intervention condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General (non-desk pedaling) physical activity</measure>
    <time_frame>Baseline (1 month period prior to program start) and post-program (immediately after program ends)</time_frame>
    <description>Self-reported physical activity</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Usual Delayed Compensation, Money</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive delayed monetary compensation with Amazon gift card, non performance-contingent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Delayed Compensation, Food</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive delayed compensation with food-based gift card, non performance-contingent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Immediate Contingent Reward, Money</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive daily performance-contingent monetary compensation with Amazon gift card.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Immediate Contingent Reward, Food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive daily performance-contingent food-based gift card.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Joint Immediate Contingent Reward, Money</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive daily performance-contingent monetary compensation with Amazon gift card, with additional compensation contingent on pedaling activity of co-worker participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Joint Immediate Contingent Reward, Food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive daily performance-contingent monetary compensation with food gift card, with additional compensation contingent on pedaling activity of co-worker participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Desk-based pedaling device and pedaling incentives provided</intervention_name>
    <description>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.</description>
    <arm_group_label>Individual Immediate Contingent Reward, Food</arm_group_label>
    <arm_group_label>Individual Immediate Contingent Reward, Money</arm_group_label>
    <arm_group_label>Joint Immediate Contingent Reward, Food</arm_group_label>
    <arm_group_label>Joint Immediate Contingent Reward, Money</arm_group_label>
    <arm_group_label>Usual Delayed Compensation, Food</arm_group_label>
    <arm_group_label>Usual Delayed Compensation, Money</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full time employee, employed at least 35 hours per week at Penn State Hershey&#xD;
&#xD;
          -  Able to provide documented approval from supervisor to participate&#xD;
&#xD;
          -  Age 18-70 years&#xD;
&#xD;
          -  Overweight or obese (BMI between 25-55)&#xD;
&#xD;
          -  Sit at desk at least 5 hours per day&#xD;
&#xD;
          -  Have regular working hours between 6 am and 6 pm on weekdays&#xD;
&#xD;
          -  Ability to understand written and spoken English&#xD;
&#xD;
          -  Own a smartphone (Android or iPhone) with Internet access&#xD;
&#xD;
          -  Willing to download cycling app on smartphone during one month study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not present in Penn State Hershey office during study period due to personal&#xD;
             circumstances such as travel/extended vacation or leave, relocation, or health-related&#xD;
             circumstances&#xD;
&#xD;
          -  Advised to only do physical activity recommended by a physician&#xD;
&#xD;
          -  Chest pain during physical activity or during prior month&#xD;
&#xD;
          -  Currently has a desk-based pedaling device or treadmill workstation already installed&#xD;
             at desk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>October 14, 2020</last_update_submitted>
  <last_update_submitted_qc>October 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Liza Rovniak</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274635
org study id: 1R21HL118453
nct id: NCT03274635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in Worker Productivity
time frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
description: Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.
measure: Elliptical Device Pedaling Quantity
time frame: 1 month (4 weeks) during pedaling program
description: Objectively-measured pedaling quantity from elliptical device
measure: User satisfaction, process evaluations
time frame: Post-program (immediately after program ends)
description: Satisfaction with intervention condition
measure: General (non-desk pedaling) physical activity
time frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
description: Self-reported physical activity
arm group label: Usual Delayed Compensation, Money
arm group type: Active Comparator
description: Will receive delayed monetary compensation with Amazon gift card, non performance-contingent.
arm group label: Usual Delayed Compensation, Food
arm group type: Active Comparator
description: Will receive delayed compensation with food-based gift card, non performance-contingent.
arm group label: Individual Immediate Contingent Reward, Money
arm group type: Experimental
description: Will receive daily performance-contingent monetary compensation with Amazon gift card.
arm group label: Individual Immediate Contingent Reward, Food
arm group type: Experimental
description: Will receive daily performance-contingent food-based gift card.
arm group label: Joint Immediate Contingent Reward, Money
arm group type: Experimental
description: Will receive daily performance-contingent monetary compensation with Amazon gift card, with additional compensation contingent on pedaling activity of co-worker participant.
arm group label: Joint Immediate Contingent Reward, Food
arm group type: Experimental
description: Will receive daily performance-contingent monetary compensation with food gift card, with additional compensation contingent on pedaling activity of co-worker participant.
intervention type: Behavioral
intervention name: Desk-based pedaling device and pedaling incentives provided
description: 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.
arm group label: Individual Immediate Contingent Reward, Food
arm group label: Individual Immediate Contingent Reward, Money
arm group label: Joint Immediate Contingent Reward, Food
arm group label: Joint Immediate Contingent Reward, Money
arm group label: Usual Delayed Compensation, Food
arm group label: Usual Delayed Compensation, Money
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Liza Rovniak
investigator title: Associate Professor
sharing ipd: No