<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/NCT03781453</url>
  </required_header>
  <id_info>
    <org_study_id>095244772</org_study_id>
    <nct_id>NCT03781453</nct_id>
  </id_info>
  <brief_title>POWERPLAY Phase 2: Development and Evaluation in Male-dominated Workplaces</brief_title>
  <official_title>POWERPLAY: Building Employee Health and Safety Through Prevention in Male-dominated Workplaces</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joan Bottorff</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Athabasca University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Melboune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Technology Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
      With funding from the Alberta Ministry of Labour (Grant #095244772), a program called&#xD;
      POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be&#xD;
      evaluated in workplaces in Alberta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In year 1, this project includes two main research components: 1. A pragmatic (real world)&#xD;
      study will be conducted employing a quasi-experimental (not a randomized controlled trial),&#xD;
      before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An&#xD;
      integrated set of research activities (systematic review, sleep behaviors and consultation&#xD;
      groups) will be used to provide the basis for developing recommendations for promoting sleep&#xD;
      health in male-dominated workplaces, and inform the development and testing of a POWERPLAY&#xD;
      sleep health module (REST-UP) in Year 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Quasi-experimental, pre-post study design</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate to Vigorous Physical Activity</measure>
    <time_frame>4 months</time_frame>
    <description>Minutes of Moderate to Vigorous physical activity will be assessed using self-report at baseline and follow-up using the Godin Leisure-Time Exercise Questionnaire (Godin &amp; Shephard, 1985). The Godin Leisure-Time Exercise Questionnaire contains three self-report questions that assess both the average frequency and duration (in minutes) of mild, moderate, and vigorous activities during free time over a typical week. Frequency and minutes are multiplied to obtain minutes per week (range from 0 and up). Weekly moderate and vigorous activity minutes will be summed and compared from baseline to follow-up, with higher scores indicating more activity. In addition, a cutoff of 150 minutes in 7 days will be used to classify participants as meeting or not meeting Canadian guidelines for physical activity at baseline and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Wellness</measure>
    <time_frame>4 months</time_frame>
    <description>Mental well-being will be assessed using the well validated Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) (Haver, Akerjordet, Caputi, Furunes, &amp; Magee, 2015; Tennant et al., 2007) at baseline and follow-up. Participants respond to 7-items (e.g., &quot;I've been feeling optimistic about the future&quot;) on a 5-point Likert scale ranging from none of the time (1) to all of the time (5), with higher scores reflecting greater mental well-being. The SWEMWBS is scored by summing the score for each of the seven items (possible range 7-35).</description>
  </primary_outcome>
  <enrollment type="Actual">498</enrollment>
  <condition>Men</condition>
  <condition>Health Behavior</condition>
  <condition>Mental Health Wellness 1</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>POWERPLAY</intervention_name>
    <description>Employees from participating worksites will be invited to completed surveys prior to and following implementation of a workplace wellness program (called &quot;POWERPLAY&quot;)</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men employed in participating workplaces, full-time or part-time, in any position&#xD;
             within the organizations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Although females may participate in the POWERPLAY program and surveys, they will not&#xD;
             be included in the evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant eligibility based on self-representation of gender identity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shell Canada Ltd (Scotford Site)</name>
      <address>
        <city>Fort Saskatchewan</city>
        <state>Alberta</state>
        <zip>T8L 4A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roper Ventures</name>
      <address>
        <city>Rocky Mountain House</city>
        <state>Alberta</state>
        <zip>T4C 1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeroxyChem</name>
      <address>
        <city>Prince George</city>
        <state>British Columbia</state>
        <zip>V2N 2S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.powerplayatwork.com/</url>
    <description>POWERPLAY program website</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Joan Bottorff</investigator_full_name>
    <investigator_title>Professor and Director of the Institute for Healthy Living and Chronic Disease Prevention</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/NCT03781453
org study id: 095244772
nct id: NCT03781453
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With funding from the Alberta Ministry of Labour (Grant #095244772), a program called
      POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be
      evaluated in workplaces in Alberta.
In year 1, this project includes two main research components: 1. A pragmatic (real world)
      study will be conducted employing a quasi-experimental (not a randomized controlled trial),
      before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An
      integrated set of research activities (systematic review, sleep behaviors and consultation
      groups) will be used to provide the basis for developing recommendations for promoting sleep
      health in male-dominated workplaces, and inform the development and testing of a POWERPLAY
      sleep health module (REST-UP) in Year 2.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Quasi-experimental, pre-post study design
primary purpose: Prevention
masking: None (Open Label)
measure: Moderate to Vigorous Physical Activity
time frame: 4 months
description: Minutes of Moderate to Vigorous physical activity will be assessed using self-report at baseline and follow-up using the Godin Leisure-Time Exercise Questionnaire (Godin & Shephard, 1985). The Godin Leisure-Time Exercise Questionnaire contains three self-report questions that assess both the average frequency and duration (in minutes) of mild, moderate, and vigorous activities during free time over a typical week. Frequency and minutes are multiplied to obtain minutes per week (range from 0 and up). Weekly moderate and vigorous activity minutes will be summed and compared from baseline to follow-up, with higher scores indicating more activity. In addition, a cutoff of 150 minutes in 7 days will be used to classify participants as meeting or not meeting Canadian guidelines for physical activity at baseline and follow-up.
measure: Mental Wellness
time frame: 4 months
description: Mental well-being will be assessed using the well validated Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) (Haver, Akerjordet, Caputi, Furunes, & Magee, 2015; Tennant et al., 2007) at baseline and follow-up. Participants respond to 7-items (e.g., "I've been feeling optimistic about the future") on a 5-point Likert scale ranging from none of the time (1) to all of the time (5), with higher scores reflecting greater mental well-being. The SWEMWBS is scored by summing the score for each of the seven items (possible range 7-35).
intervention type: Behavioral
intervention name: POWERPLAY
description: Employees from participating worksites will be invited to completed surveys prior to and following implementation of a workplace wellness program (called "POWERPLAY")
criteria: 
gender: Male
gender based: Yes
gender description: Participant eligibility based on self-representation of gender identity
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Canada
url: http://www.powerplayatwork.com/
description: POWERPLAY program website
responsible party type: Sponsor-Investigator
investigator affiliation: University of British Columbia
investigator full name: Joan Bottorff
investigator title: Professor and Director of the Institute for Healthy Living and Chronic Disease Prevention
sharing ipd: No