<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/NCT03295136</url>
  </required_header>
  <id_info>
    <org_study_id>WRK-HMO-CTIL</org_study_id>
    <nct_id>NCT03295136</nct_id>
  </id_info>
  <brief_title>Impact of Employee Health Promotion Course on Health Promotion in the Work Place.</brief_title>
  <official_title>Impact of Health Promotion Course for Female Employees on Health Promotion in the Work Place.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</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>
      People of working age spend most of their day at work, and usually have less time to&#xD;
      participate in other activities, the work day in Israel being one of the longest in the OECD.&#xD;
      Work places, therefore, present the most suitable setting for health interventions, as they&#xD;
      are an accessible and available framework and have real potential of creating change.&#xD;
&#xD;
      The current Health Promotion in the Work Place training course aims to train female employees&#xD;
      to design, implement, and evaluate a health promotion program in their workplace, as well as&#xD;
      promote personal change in improving healthy habits, and empowering the participants. A&#xD;
      unique course has been designed, consisting of 20 sessions- 15 consecutive sessions, and 5&#xD;
      maintenance sessions throughout the year. The course will focus on acquiring health knowledge&#xD;
      and health promotion skills, as well as leadership skills and empowerment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor health of employees can cause absences, lack of continuous service, decreased output or&#xD;
      productions, fatigue or lack of concentration, and eventually financial damage to the&#xD;
      employer. Research shows that health promotion programs in the work place improve employee's&#xD;
      physical and emotional health, as well as their sense of commitment, belonging, and&#xD;
      responsibility.&#xD;
&#xD;
      People of working age spend most of their day at work, and usually have less time to&#xD;
      participate in other activities, the work day in Israel being one of the longest in the OECD.&#xD;
      Work places, therefore, present the most suitable setting for health interventions, as they&#xD;
      are an accessible and available framework and have real potential of creating change.&#xD;
&#xD;
      The current Health Promotion in the Work Place training course aims to train female employees&#xD;
      to design, implement, and evaluate a health promotion program in their workplace, as well as&#xD;
      promote personal change in improving healthy habits, and empowering the participants.&#xD;
      Objectives include improving eating habits, increasing engagement in physical activity,&#xD;
      increasing self-efficacy, and designing a detailed health promotion program in the work&#xD;
      place, based on it's needs, and implementing it there.&#xD;
&#xD;
      In order to accomplish these objectives, a unique course has been designed, consisting of 20&#xD;
      sessions- 15 consecutive sessions, and 5 maintenance sessions throughout the year. The course&#xD;
      will focus on acquiring health knowledge and health promotion skills, as well as leadership&#xD;
      skills and empowerment. The participants will learn how to build programs, market them to&#xD;
      their coworkers and employers, budget them, recruit partners, create a Gantt charts,&#xD;
      implement and evaluate. The maintenance sessions will take place in different work places, so&#xD;
      that the participants can showcase their projects.&#xD;
&#xD;
      Data will be collected at baseline and 2 post interventions follow up points (after 15 weeks&#xD;
      and after one year).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study includes a pre/post study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Nutrition Habits</measure>
    <time_frame>At baseline, 15 weeks after intervention initiation, and one year post intervention.</time_frame>
    <description>Participants complete self report survey indicating their eating habits, including consumption of sweets, sweet beverages, fruits and vegetables, whole grains, and legumes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical Activity Habits</measure>
    <time_frame>At baseline, 15 weeks after intervention initiation, and one year post intervention.</time_frame>
    <description>Participants complete self report survey indicating their physical activity habits, including minutes of engaging in vigorous and moderate physical activity. Measures will include average daily minutes of engaging in physical activity, and adherence to WHO recommendation (150 minutes of moderate physical activity a week, or 75 minutes of vigorous physical activity a week).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Promotion projects in the Work Place</measure>
    <time_frame>One year post intervention</time_frame>
    <description>Each participant will have implemented a health promotion project in their workplace, according to the timeline and goals defined in each project. This will be assessed through phone interviews with the participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self Efficacy</measure>
    <time_frame>At baseline, 15 weeks after intervention initiation, and one year post intervention.</time_frame>
    <description>Self Efficacy will be assessed through self report questionnaires, assessing participants self efficacy regarding their leadership skills, ability to implement a health promotion project, create partnerships, evaluate a project, and influence women in their community.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular disease knowledge</measure>
    <time_frame>At baseline, 15 weeks after intervention initiation, and one year post intervention.</time_frame>
    <description>Cardiovascular disease knowledge will be assessed through a self report questionnaire based on the American Heart Association's Cardiovascular disease knowledge survey items</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Lifestyle Risk Reduction</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <condition>Empowerment</condition>
  <arm_group>
    <arm_group_label>Health Promotion Training for Women Employees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups of women employees will participate in a 20 session health promotion training course. The course will include health education and health promotion knowledge and skills, as well as leadership and project building skills, including empowerment, change process, recruiting partners and more. The first 15 sessions will be weekly session, while the remaining five will take place every couple of months throughout the following year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Promotion Training for Women Employees</intervention_name>
    <description>Group intervention over a one year, acquiring health promotion tools and skills, as well as leadership and project designing and implementation skills.</description>
    <arm_group_label>Health Promotion Training for Women Employees</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female employees from governmental offices and private organizations, willingness to&#xD;
             commit to participation in the health promotion training course and lead a health&#xD;
             promotion project in their place of work, willingness to make make personal change.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna R Zwas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization, Jerusalem, Isreal</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Baxter S, Sanderson K, Venn AJ, Blizzard CL, Palmer AJ. The relationship between return on investment and quality of study methodology in workplace health promotion programs. Am J Health Promot. 2014 Jul-Aug;28(6):347-63. doi: 10.4278/ajhp.130731-LIT-395.</citation>
    <PMID>24977496</PMID>
  </reference>
  <reference>
    <citation>VanWormer JJ, Boucher JL, Sidebottom AC. Two-year impact of lifestyle changes on workplace productivity loss in the Heart of New Ulm Project. Occup Environ Med. 2015 Jun;72(6):460-2. doi: 10.1136/oemed-2014-102620. Epub 2015 Apr 9.</citation>
    <PMID>25858035</PMID>
  </reference>
  <reference>
    <citation>Leigh JP. Economic burden of occupational injury and illness in the United States. Milbank Q. 2011 Dec;89(4):728-72. doi: 10.1111/j.1468-0009.2011.00648.x.</citation>
    <PMID>22188353</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>April 23, 2023</last_update_submitted>
  <last_update_submitted_qc>April 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Donna R Zwas</investigator_full_name>
    <investigator_title>Director of Linda Joy Pollin Cardiovascular Wellness Center for Women</investigator_title>
  </responsible_party>
  <!-- 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/NCT03295136
org study id: WRK-HMO-CTIL
nct id: NCT03295136
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People of working age spend most of their day at work, and usually have less time to
      participate in other activities, the work day in Israel being one of the longest in the OECD.
      Work places, therefore, present the most suitable setting for health interventions, as they
      are an accessible and available framework and have real potential of creating change.

      The current Health Promotion in the Work Place training course aims to train female employees
      to design, implement, and evaluate a health promotion program in their workplace, as well as
      promote personal change in improving healthy habits, and empowering the participants. A
      unique course has been designed, consisting of 20 sessions- 15 consecutive sessions, and 5
      maintenance sessions throughout the year. The course will focus on acquiring health knowledge
      and health promotion skills, as well as leadership skills and empowerment.
Poor health of employees can cause absences, lack of continuous service, decreased output or
      productions, fatigue or lack of concentration, and eventually financial damage to the
      employer. Research shows that health promotion programs in the work place improve employee's
      physical and emotional health, as well as their sense of commitment, belonging, and
      responsibility.

      People of working age spend most of their day at work, and usually have less time to
      participate in other activities, the work day in Israel being one of the longest in the OECD.
      Work places, therefore, present the most suitable setting for health interventions, as they
      are an accessible and available framework and have real potential of creating change.

      The current Health Promotion in the Work Place training course aims to train female employees
      to design, implement, and evaluate a health promotion program in their workplace, as well as
      promote personal change in improving healthy habits, and empowering the participants.
      Objectives include improving eating habits, increasing engagement in physical activity,
      increasing self-efficacy, and designing a detailed health promotion program in the work
      place, based on it's needs, and implementing it there.

      In order to accomplish these objectives, a unique course has been designed, consisting of 20
      sessions- 15 consecutive sessions, and 5 maintenance sessions throughout the year. The course
      will focus on acquiring health knowledge and health promotion skills, as well as leadership
      skills and empowerment. The participants will learn how to build programs, market them to
      their coworkers and employers, budget them, recruit partners, create a Gantt charts,
      implement and evaluate. The maintenance sessions will take place in different work places, so
      that the participants can showcase their projects.

      Data will be collected at baseline and 2 post interventions follow up points (after 15 weeks
      and after one year).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study includes a pre/post study.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Nutrition Habits
time frame: At baseline, 15 weeks after intervention initiation, and one year post intervention.
description: Participants complete self report survey indicating their eating habits, including consumption of sweets, sweet beverages, fruits and vegetables, whole grains, and legumes.
measure: Change in Physical Activity Habits
time frame: At baseline, 15 weeks after intervention initiation, and one year post intervention.
description: Participants complete self report survey indicating their physical activity habits, including minutes of engaging in vigorous and moderate physical activity. Measures will include average daily minutes of engaging in physical activity, and adherence to WHO recommendation (150 minutes of moderate physical activity a week, or 75 minutes of vigorous physical activity a week).
measure: Health Promotion projects in the Work Place
time frame: One year post intervention
description: Each participant will have implemented a health promotion project in their workplace, according to the timeline and goals defined in each project. This will be assessed through phone interviews with the participants.
measure: Change in Self Efficacy
time frame: At baseline, 15 weeks after intervention initiation, and one year post intervention.
description: Self Efficacy will be assessed through self report questionnaires, assessing participants self efficacy regarding their leadership skills, ability to implement a health promotion project, create partnerships, evaluate a project, and influence women in their community.
measure: Change in cardiovascular disease knowledge
time frame: At baseline, 15 weeks after intervention initiation, and one year post intervention.
description: Cardiovascular disease knowledge will be assessed through a self report questionnaire based on the American Heart Association's Cardiovascular disease knowledge survey items
arm group label: Health Promotion Training for Women Employees
arm group type: Experimental
description: Groups of women employees will participate in a 20 session health promotion training course. The course will include health education and health promotion knowledge and skills, as well as leadership and project building skills, including empowerment, change process, recruiting partners and more. The first 15 sessions will be weekly session, while the remaining five will take place every couple of months throughout the following year.
intervention type: Behavioral
intervention name: Health Promotion Training for Women Employees
description: Group intervention over a one year, acquiring health promotion tools and skills, as well as leadership and project designing and implementation skills.
arm group label: Health Promotion Training for Women Employees
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Donna R Zwas, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
country: Israel
citation: Baxter S, Sanderson K, Venn AJ, Blizzard CL, Palmer AJ. The relationship between return on investment and quality of study methodology in workplace health promotion programs. Am J Health Promot. 2014 Jul-Aug;28(6):347-63. doi: 10.4278/ajhp.130731-LIT-395.
PMID: 24977496
citation: VanWormer JJ, Boucher JL, Sidebottom AC. Two-year impact of lifestyle changes on workplace productivity loss in the Heart of New Ulm Project. Occup Environ Med. 2015 Jun;72(6):460-2. doi: 10.1136/oemed-2014-102620. Epub 2015 Apr 9.
PMID: 25858035
citation: Leigh JP. Economic burden of occupational injury and illness in the United States. Milbank Q. 2011 Dec;89(4):728-72. doi: 10.1111/j.1468-0009.2011.00648.x.
PMID: 22188353
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Donna R Zwas
investigator title: Director of Linda Joy Pollin Cardiovascular Wellness Center for Women