<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/NCT02206113</url>
  </required_header>
  <id_info>
    <org_study_id>3989-1</org_study_id>
    <nct_id>NCT02206113</nct_id>
  </id_info>
  <brief_title>Sit to Stand Intervention for Allina Health Employees</brief_title>
  <official_title>A Sit-to-Stand Intervention for Allina Health Employees: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allina Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 16 week pilot study for Allina call center employees to look at the psychological outcomes&#xD;
      and biological markers after an intervention of using a standing work station. There were two&#xD;
      groups: group 1 received, and was instructed to use, the standing work station for all 16&#xD;
      weeks, group 2 was a wait-list control group and received, and was instructed to use, the&#xD;
      standing work station for the second 8 weeks. Psychological outcomes were measured at weeks&#xD;
      0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-reported quality of life</measure>
    <time_frame>Baseline, week 4, week 8, week 12, week 16</time_frame>
    <description>Change in quality of life will be measured through the administration of the PROMIS-29 questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Baseline, Week 8, Week 16</time_frame>
    <description>Waist circumference measured in inches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of minutes stood per day</measure>
    <time_frame>Baseline, week 8, week 16</time_frame>
    <description>Participants recorded their number of minutes stood at work daily from baseline through week 16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported stress</measure>
    <time_frame>Baseline, week 4, week 8, week 12, week 16</time_frame>
    <description>Change in stress will be measured through the administration of the Perceived Stress Scale (PSS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health promotion and lifestyle choices</measure>
    <time_frame>Baseline, week 4, week 8, week 12, week 16</time_frame>
    <description>Change in health promotion and lifestyle choices will be measured through the administration of the Health Promoting Lifestyle Profile Questionnaire (HPLP-II).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in workplace productivity</measure>
    <time_frame>Baseline, week 4, week 8, week 12, week 16</time_frame>
    <description>Change in workplace productivity will be measured through the administration of Workplace Productivity and Activity Impairment (WPAI) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported physical activity levels</measure>
    <time_frame>Baseline, week 4, week 8, week 12, week 16</time_frame>
    <description>Change in self-reported physical activity levels will be measured through the administration of the International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Baseline, Week 8, Week 16</time_frame>
    <description>Change in an individual's BMI after being weighed at baseline, week 8, and week 16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body fat percentage</measure>
    <time_frame>Baseline, week 8, week 16</time_frame>
    <description>Change in body fat percentage as measured by a BodPod® Assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>Baseline, week 8, week 16</time_frame>
    <description>Change in resting heart rate from baseline to week 16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure (systolic and diastolic)</measure>
    <time_frame>Baseline, week 8, week 16</time_frame>
    <description>Change in both systolic and diastolic blood pressure from baseline to week 16.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Stress</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Standing workstation - 16 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm, Standing workstation - 16 weeks, received the intervention of a standing workstation for 16 weeks. For the first 8 weeks, the participants were instructed how long to stand per hour for an 8 hour shift. The second 8 weeks their use was monitored for sustainability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standing workstation - second 8 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm, Standing workstation - second 8 weeks, received the intervention of a standing workstation for 8 weeks of the study. For the first 8 weeks, the worked at their normal desks without an intervention. The second 8 weeks they received a standing workstation and their use was monitored.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standing workstation</intervention_name>
    <arm_group_label>Standing workstation - 16 weeks</arm_group_label>
    <arm_group_label>Standing workstation - second 8 weeks</arm_group_label>
    <other_name>Ergotron Workfit-S</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Allina Health Call Center Employee (75% or higher employee status)&#xD;
&#xD;
          -  Aged 18 to 65 years&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to stand for 20 minutes continuously unaided&#xD;
&#xD;
          -  Home based employees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffery Dusek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allina Health</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>January 26, 2015</last_update_submitted>
  <last_update_submitted_qc>January 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Standing workstation</keyword>
  <!-- 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/NCT02206113
org study id: 3989-1
nct id: NCT02206113
lead sponsor: 
has dmc: No
A 16 week pilot study for Allina call center employees to look at the psychological outcomes
      and biological markers after an intervention of using a standing work station. There were two
      groups: group 1 received, and was instructed to use, the standing work station for all 16
      weeks, group 2 was a wait-list control group and received, and was instructed to use, the
      standing work station for the second 8 weeks. Psychological outcomes were measured at weeks
      0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.
allocation: Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Change in self-reported quality of life
time frame: Baseline, week 4, week 8, week 12, week 16
description: Change in quality of life will be measured through the administration of the PROMIS-29 questionnaire.
measure: Change in waist circumference
time frame: Baseline, Week 8, Week 16
description: Waist circumference measured in inches
measure: Change in number of minutes stood per day
time frame: Baseline, week 8, week 16
description: Participants recorded their number of minutes stood at work daily from baseline through week 16.
measure: Change in self-reported stress
time frame: Baseline, week 4, week 8, week 12, week 16
description: Change in stress will be measured through the administration of the Perceived Stress Scale (PSS).
measure: Change in health promotion and lifestyle choices
time frame: Baseline, week 4, week 8, week 12, week 16
description: Change in health promotion and lifestyle choices will be measured through the administration of the Health Promoting Lifestyle Profile Questionnaire (HPLP-II).
measure: Change in workplace productivity
time frame: Baseline, week 4, week 8, week 12, week 16
description: Change in workplace productivity will be measured through the administration of Workplace Productivity and Activity Impairment (WPAI) questionnaire.
measure: Change in self-reported physical activity levels
time frame: Baseline, week 4, week 8, week 12, week 16
description: Change in self-reported physical activity levels will be measured through the administration of the International Physical Activity Questionnaire (IPAQ)
measure: Change in Body Mass Index (BMI)
time frame: Baseline, Week 8, Week 16
description: Change in an individual's BMI after being weighed at baseline, week 8, and week 16.
measure: Change in body fat percentage
time frame: Baseline, week 8, week 16
description: Change in body fat percentage as measured by a BodPod® Assessment.
measure: Change in resting heart rate
time frame: Baseline, week 8, week 16
description: Change in resting heart rate from baseline to week 16.
measure: Change in blood pressure (systolic and diastolic)
time frame: Baseline, week 8, week 16
description: Change in both systolic and diastolic blood pressure from baseline to week 16.
arm group label: Standing workstation - 16 weeks
arm group type: Experimental
description: This arm, Standing workstation - 16 weeks, received the intervention of a standing workstation for 16 weeks. For the first 8 weeks, the participants were instructed how long to stand per hour for an 8 hour shift. The second 8 weeks their use was monitored for sustainability.
arm group label: Standing workstation - second 8 weeks
arm group type: Active Comparator
description: This arm, Standing workstation - second 8 weeks, received the intervention of a standing workstation for 8 weeks of the study. For the first 8 weeks, the worked at their normal desks without an intervention. The second 8 weeks they received a standing workstation and their use was monitored.
intervention type: Behavioral
intervention name: Standing workstation
arm group label: Standing workstation - 16 weeks
arm group label: Standing workstation - second 8 weeks
other name: Ergotron Workfit-S
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffery Dusek, PhD
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Sponsor