<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/NCT02215239</url>
  </required_header>
  <id_info>
    <org_study_id>201310041RINA</org_study_id>
    <nct_id>NCT02215239</nct_id>
  </id_info>
  <brief_title>Development of Workplace Physical Activity Promotion Models in Taiwan</brief_title>
  <official_title>Development of Workplace Physical Activity Promotion Models in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness of intervention applying WHO&#xD;
      Healthy Workplace Framework and Model to enhance the level of physical activity on employees.&#xD;
      This research is an experimental intervention study recruiting two working types in four&#xD;
      workplaces. Two working types are: (1) Working type A: Workers tend to be seated during work&#xD;
      hours. Two telecommunications enterprises will respectively stand for the experiment group&#xD;
      and the control group. (2) Working type B: Workers tend to be standing during work hours.&#xD;
      Likewise, two different enterprises will respectively stand for the experiment group and the&#xD;
      control group. Purposive sampling method will be used to select the experiment group. The&#xD;
      intervention plan is to implement a cyclic or iterative process recommended by WHO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several evidences have shown that regular physical activity could benefit not only to a&#xD;
      healthy lifestyle, but also reduce mortality rate. However, the number of people who perform&#xD;
      regular physical activity are still in a low proportion of world population. In Taiwan,&#xD;
      people are mostly inactive and have low level of physical activity at their workplaces.&#xD;
      Therefore, developing a healthy workplace could encourage employees to get into the habit of&#xD;
      regular exercise, relieve stress, improve interaction of social activity and build a healthy&#xD;
      life style. Meanwhile, regular exercise could improve coherence, morale and higher&#xD;
      satisfaction, productive efficiency, corporate image and competitiveness. Previous studies&#xD;
      have shown inconsistent effects in promoting physical activity in the workplace. Therefore,&#xD;
      determining the effects of comprehensive model using in interventions at workplaces is&#xD;
      needed. . The purpose of this study is to investigate the effectiveness of intervention&#xD;
      applying WHO Healthy Workplace Framework and Model to enhance the level of physical activity&#xD;
      on employees. This research is an experimental intervention study recruiting two working&#xD;
      types in four workplaces. Two working types are: (1) Working type A: Workers tend to be&#xD;
      seated during work hours. Two telecommunications enterprises will respectively stand for the&#xD;
      experiment group and the control group. (2) Working type B: Workers tend to be standing&#xD;
      during work hours. Likewise, two different enterprises will respectively stand for the&#xD;
      experiment group and the control group. The intervention plan is to implement a cyclic or&#xD;
      iterative process recommended by WHO. The process includes eight steps: (1) Mobilize; (2)&#xD;
      Assemble; (3) Assess; (4) Prioritize; (5) Plan; (6) Do; (7) Evaluate; (8) Improve. By gaining&#xD;
      the commitment from the highest authority in the enterprise and communicated to all workers&#xD;
      and their representatives, we will be able to assemble a Healthy Workplace Team who will work&#xD;
      on implementing change in the workplace. As well as assembling the Team, it is also essential&#xD;
      to assemble other resources that will be required, such as locations, time, budgets or&#xD;
      working supplies, to ensure the committee has the resources necessary to do the work.&#xD;
      Assessments on both the present situation of the enterprise and the present situation with&#xD;
      respect to the health of workers are required in order to set priorities among the many&#xD;
      issues identified. When developing a health plan, we focus on different phases of exercise&#xD;
      and prescribe individualized physical activity program., in the mean while, the power of&#xD;
      social learning and environmental support are critical in making a sustainable improvement in&#xD;
      the workplace. The details of the actions to be taken may contain educational workshop,&#xD;
      pedometer using, setting fixed period of time for physical activities, providing excellent&#xD;
      health and fitness improvement prize, email and text reminder about exercise information,&#xD;
      holding outdoor physical activities on a regular time schedule for employee, and propagating&#xD;
      internal and external resources. Re-evaluation and modification will be performed at the end&#xD;
      of 16-weeks intervention, and then the second year's study will be planned and designed. In&#xD;
      the present study, before intervention, we will require a confidential survey and health risk&#xD;
      assessments about personal health condition base on employees will. The assessments include&#xD;
      basic data and medical record, level of physical activity, health-related fitness, sleep&#xD;
      quality and daytime sleepiness, depression scale, exercise stages, self-evaluation of fitness&#xD;
      and exercise capacity, self-efficacy in exercise, SmartIn(SI) system, and working performance&#xD;
      evaluation. The purpose of the study is to access the effect of implementing The WHO Healthy&#xD;
      Workplace Framework and Model on different working types in different workplaces, by&#xD;
      developing method that address the physical and psychosocial working environments, as well as&#xD;
      promoting workers' health and creating health-promoting working environments, the result is&#xD;
      expected to provide better information for the Health Promotion Administration in future&#xD;
      policy-making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of health-related physical fitness from baseline to 16-week</measure>
    <time_frame>16 weeks</time_frame>
    <description>Health-related physical fitness including:&#xD;
body composition (body weight, height, waist and hip circumferences)&#xD;
flexibility (sit-to-reach, cm)&#xD;
muscle strength (grip strength of dominant hand, kg)&#xD;
muscle endurance (sit-up in one minute, times/min)&#xD;
cardiopulmonary endurance (stepping in three minutes, heart rate and physical exercise index)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of physical activity from baseline to 16-week</measure>
    <time_frame>16 weeks</time_frame>
    <description>Using 7-Day Physical Activity Recall questionnaire and actigraph to investigate level of physical activity in the participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of sleep quality from baseline to 16-week</measure>
    <time_frame>16 weeks</time_frame>
    <description>Using Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and actigraph to investigate sleep quality in the participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of depression symptoms from baseline to 16-week</measure>
    <time_frame>16 weeks</time_frame>
    <description>Using Center for Epidemiologic Studies Depression Scale to investigate level of depression in the participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of stress from baseline to 16-week</measure>
    <time_frame>16 weeks</time_frame>
    <description>Using SmartIn system to investigate level of psychological stress in the participants</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Occupational Health</condition>
  <arm_group>
    <arm_group_label>Working type A &amp; Workplace intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants: Workers tend to be seated during work hours. Intervention: WHO Healthy Workplace Framework and Model. Duration: 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Working type A &amp; Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants: Workers tend to be standing during work hours. Intervention: Usual care. Duration: 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Working type B &amp; Workplace intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants: Workers tend to be standing during work hours. Intervention: WHO Healthy Workplace Framework and Model. Duration: 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Working type B &amp; Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants: Workers tend to be standing during work hours. Intervention: Usual care. Duration: 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Workplace intervention</intervention_name>
    <description>WHO Healthy Workplace Framework and Model. The intervention plan is to implement a cyclic or iterative process recommended by WHO. The process includes eight steps: (1) Mobilize; (2) Assemble; (3) Assess; (4) Prioritize; (5) Plan; (6) Do; (7) Evaluate; (8) Improve. We focus on different phases of exercise and prescribe individualized physical activity program.</description>
    <arm_group_label>Working type A &amp; Workplace intervention</arm_group_label>
    <arm_group_label>Working type B &amp; Workplace intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Workers tend to be seated or standing during work hours.&#xD;
&#xD;
          -  Basic capability to read or verbal communication in Chinese.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  No other critical diseases or unstable cardiopulmonary disease, diabetes, hypertension&#xD;
             or neurological diseases.&#xD;
&#xD;
          -  No pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meng-Yueh Chien</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meng-Yueh Chien, Doctor</last_name>
    <phone>+886-2-33668141</phone>
    <email>mychien@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>115</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meng-Yueh Chien, Doctor</last_name>
      <phone>02-33668141</phone>
      <email>mychien@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 13, 2015</last_update_submitted>
  <last_update_submitted_qc>March 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health lifestyle</keyword>
  <keyword>health promotion</keyword>
  <keyword>occupational health</keyword>
  <keyword>Work site health promotion</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/NCT02215239
org study id: 201310041RINA
nct id: NCT02215239
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effectiveness of intervention applying WHO
      Healthy Workplace Framework and Model to enhance the level of physical activity on employees.
      This research is an experimental intervention study recruiting two working types in four
      workplaces. Two working types are: (1) Working type A: Workers tend to be seated during work
      hours. Two telecommunications enterprises will respectively stand for the experiment group
      and the control group. (2) Working type B: Workers tend to be standing during work hours.
      Likewise, two different enterprises will respectively stand for the experiment group and the
      control group. Purposive sampling method will be used to select the experiment group. The
      intervention plan is to implement a cyclic or iterative process recommended by WHO.
Several evidences have shown that regular physical activity could benefit not only to a
      healthy lifestyle, but also reduce mortality rate. However, the number of people who perform
      regular physical activity are still in a low proportion of world population. In Taiwan,
      people are mostly inactive and have low level of physical activity at their workplaces.
      Therefore, developing a healthy workplace could encourage employees to get into the habit of
      regular exercise, relieve stress, improve interaction of social activity and build a healthy
      life style. Meanwhile, regular exercise could improve coherence, morale and higher
      satisfaction, productive efficiency, corporate image and competitiveness. Previous studies
      have shown inconsistent effects in promoting physical activity in the workplace. Therefore,
      determining the effects of comprehensive model using in interventions at workplaces is
      needed. . The purpose of this study is to investigate the effectiveness of intervention
      applying WHO Healthy Workplace Framework and Model to enhance the level of physical activity
      on employees. This research is an experimental intervention study recruiting two working
      types in four workplaces. Two working types are: (1) Working type A: Workers tend to be
      seated during work hours. Two telecommunications enterprises will respectively stand for the
      experiment group and the control group. (2) Working type B: Workers tend to be standing
      during work hours. Likewise, two different enterprises will respectively stand for the
      experiment group and the control group. The intervention plan is to implement a cyclic or
      iterative process recommended by WHO. The process includes eight steps: (1) Mobilize; (2)
      Assemble; (3) Assess; (4) Prioritize; (5) Plan; (6) Do; (7) Evaluate; (8) Improve. By gaining
      the commitment from the highest authority in the enterprise and communicated to all workers
      and their representatives, we will be able to assemble a Healthy Workplace Team who will work
      on implementing change in the workplace. As well as assembling the Team, it is also essential
      to assemble other resources that will be required, such as locations, time, budgets or
      working supplies, to ensure the committee has the resources necessary to do the work.
      Assessments on both the present situation of the enterprise and the present situation with
      respect to the health of workers are required in order to set priorities among the many
      issues identified. When developing a health plan, we focus on different phases of exercise
      and prescribe individualized physical activity program., in the mean while, the power of
      social learning and environmental support are critical in making a sustainable improvement in
      the workplace. The details of the actions to be taken may contain educational workshop,
      pedometer using, setting fixed period of time for physical activities, providing excellent
      health and fitness improvement prize, email and text reminder about exercise information,
      holding outdoor physical activities on a regular time schedule for employee, and propagating
      internal and external resources. Re-evaluation and modification will be performed at the end
      of 16-weeks intervention, and then the second year's study will be planned and designed. In
      the present study, before intervention, we will require a confidential survey and health risk
      assessments about personal health condition base on employees will. The assessments include
      basic data and medical record, level of physical activity, health-related fitness, sleep
      quality and daytime sleepiness, depression scale, exercise stages, self-evaluation of fitness
      and exercise capacity, self-efficacy in exercise, SmartIn(SI) system, and working performance
      evaluation. The purpose of the study is to access the effect of implementing The WHO Healthy
      Workplace Framework and Model on different working types in different workplaces, by
      developing method that address the physical and psychosocial working environments, as well as
      promoting workers' health and creating health-promoting working environments, the result is
      expected to provide better information for the Health Promotion Administration in future
      policy-making.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change of health-related physical fitness from baseline to 16-week
time frame: 16 weeks
description: Health-related physical fitness including:
body composition (body weight, height, waist and hip circumferences)
flexibility (sit-to-reach, cm)
muscle strength (grip strength of dominant hand, kg)
muscle endurance (sit-up in one minute, times/min)
cardiopulmonary endurance (stepping in three minutes, heart rate and physical exercise index)
measure: Change of physical activity from baseline to 16-week
time frame: 16 weeks
description: Using 7-Day Physical Activity Recall questionnaire and actigraph to investigate level of physical activity in the participants
measure: Change of sleep quality from baseline to 16-week
time frame: 16 weeks
description: Using Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and actigraph to investigate sleep quality in the participants
measure: Change of depression symptoms from baseline to 16-week
time frame: 16 weeks
description: Using Center for Epidemiologic Studies Depression Scale to investigate level of depression in the participants
measure: Change of stress from baseline to 16-week
time frame: 16 weeks
description: Using SmartIn system to investigate level of psychological stress in the participants
arm group label: Working type A & Workplace intervention
arm group type: Experimental
description: Participants: Workers tend to be seated during work hours. Intervention: WHO Healthy Workplace Framework and Model. Duration: 16 weeks.
arm group label: Working type A & Usual care
arm group type: No Intervention
description: Participants: Workers tend to be standing during work hours. Intervention: Usual care. Duration: 16 weeks.
arm group label: Working type B & Workplace intervention
arm group type: Experimental
description: Participants: Workers tend to be standing during work hours. Intervention: WHO Healthy Workplace Framework and Model. Duration: 16 weeks.
arm group label: Working type B & Usual care
arm group type: No Intervention
description: Participants: Workers tend to be standing during work hours. Intervention: Usual care. Duration: 16 weeks.
intervention type: Behavioral
intervention name: Workplace intervention
description: WHO Healthy Workplace Framework and Model. The intervention plan is to implement a cyclic or iterative process recommended by WHO. The process includes eight steps: (1) Mobilize; (2) Assemble; (3) Assess; (4) Prioritize; (5) Plan; (6) Do; (7) Evaluate; (8) Improve. We focus on different phases of exercise and prescribe individualized physical activity program.
arm group label: Working type A & Workplace intervention
arm group label: Working type B & Workplace intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meng-Yueh Chien
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Meng-Yueh Chien, Doctor
phone: +886-2-33668141
email: mychien@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor