<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/NCT04500977</url>
  </required_header>
  <id_info>
    <org_study_id>LDSP-HMO-CTIL</org_study_id>
    <nct_id>NCT04500977</nct_id>
  </id_info>
  <brief_title>Training Health Promotion Women Community Leaders</brief_title>
  <official_title>Womens Leadership Intervention Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jerusalem Municipality</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Goal of the Program:&#xD;
&#xD;
      To develop personal and group ability for participants in the DPP to plan and implement&#xD;
      health promotion programs.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Develop skills in the planning, implementation, and assessment of community-based health&#xD;
           promotion programs&#xD;
&#xD;
        2. Personal, group and community capacity development in health promotion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants were graduates of our previously implemented diabetes prevention program&#xD;
      (DPP), in which women learned the health dangers involved in a sendentary life style, and&#xD;
      unhealthy diet, a lack of planned physical activity, insufficient personal health management,&#xD;
      and smoking. The importacne of adopting a healthy lifestyle, and how to achieve this goal was&#xD;
      stressed. The 24 graduates most motivated to empower others were chosen to take part in this&#xD;
      12 session leadership program. In the leadership program, women were taught more about the&#xD;
      manner in which to bring about a change in one's health by adopting a healthy lifestyle,&#xD;
      leadership, and facilitation skills and the development, implementation, and evaluation&#xD;
      process required to conduct a community program that will impact society as a whole. Women&#xD;
      learned how to map needs and resources, define goals and objectives, implement and evaluate a&#xD;
      community based program. Following frontal training, three action grousp were established.&#xD;
      Each group was responsible for developing and implementing a program in the community.&#xD;
      Programs based on initiatives set during the first stage of the DPP included: working in&#xD;
      schools to promote a healthy lifestyle, community work targeting non-working/homemaker women&#xD;
      ages 25+, enhancing physical activity in the community, and empowering teens. Together, all&#xD;
      of these initiatives: increased awareness of fast food dangers, increased awareness to the&#xD;
      dangers of nargillah smoking, and increased awareness as to the importance of physical&#xD;
      activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2025</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>Training of community members in leadership and community-based health promotion skills</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Program implementation</measure>
    <time_frame>12 months after completion of the course</time_frame>
    <description>Three programs will be implemented by the group within 12 months of initiation of the course.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RE-AIM assessment of intervention quality</measure>
    <time_frame>12 months after completion of the course</time_frame>
    <description>The RE-AIM assessment tool assesses Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention programs. Each domain is assessed by questions adapted from the RE-AIM framework. Each item is scored as fully implemented, partially implemented or not implemented, with 0 as not, 0.5 as partially and 1.0 as fully, The questions for each item are averaged for a score that ranges from 0-1, with one being full implementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>health promotion leadership self efficacy</measure>
    <time_frame>upon completion of the course, approximately 14 weeks after initiating the intervention.</time_frame>
    <description>13 item questionnaire with scores ranging from 13- 52, with 52 representing higher self efficacy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sedentary Behavior</condition>
  <condition>Risk Reduction</condition>
  <arm_group>
    <arm_group_label>Training community health promotion leaderss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community women are trained in leadership and community-based health promotion skills</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>leadership empowerment</intervention_name>
    <description>In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adapting a healthy life style, leadership and facilitation skills and the development, implementation and evaluation process required to conduct a community program that will impact society. Women learned how to map needs and resources, define goals and objectives, develop, implement and evaluate a community based program.</description>
    <arm_group_label>Training community health promotion leaderss</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had to previously take part in the previously implemented diabetes prevention program&#xD;
             (DPP)&#xD;
&#xD;
          -  had to have interest and ability in developing programs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>As per self-identification</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Zwas, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donna Zwas, MD MPH</last_name>
    <phone>972504048274</phone>
    <email>donnaz1818@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rivka May, BS</last_name>
    <phone>972505406064</phone>
    <email>rivkatmay@hadassah.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donna Zwas, MD MPH</last_name>
      <phone>972504048274</phone>
      <email>donnaz1818@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rivka May, bs</last_name>
      <phone>972505406064</phone>
      <email>rivkatmay@hadassah.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>March 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>deidentified data may be shared upon reasonable investigator request</ipd_description>
  </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/NCT04500977
org study id: LDSP-HMO-CTIL
nct id: NCT04500977
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Goal of the Program:

      To develop personal and group ability for participants in the DPP to plan and implement
      health promotion programs.

      Objectives:

        1. Develop skills in the planning, implementation, and assessment of community-based health
           promotion programs

        2. Personal, group and community capacity development in health promotion
All participants were graduates of our previously implemented diabetes prevention program
      (DPP), in which women learned the health dangers involved in a sendentary life style, and
      unhealthy diet, a lack of planned physical activity, insufficient personal health management,
      and smoking. The importacne of adopting a healthy lifestyle, and how to achieve this goal was
      stressed. The 24 graduates most motivated to empower others were chosen to take part in this
      12 session leadership program. In the leadership program, women were taught more about the
      manner in which to bring about a change in one's health by adopting a healthy lifestyle,
      leadership, and facilitation skills and the development, implementation, and evaluation
      process required to conduct a community program that will impact society as a whole. Women
      learned how to map needs and resources, define goals and objectives, implement and evaluate a
      community based program. Following frontal training, three action grousp were established.
      Each group was responsible for developing and implementing a program in the community.
      Programs based on initiatives set during the first stage of the DPP included: working in
      schools to promote a healthy lifestyle, community work targeting non-working/homemaker women
      ages 25+, enhancing physical activity in the community, and empowering teens. Together, all
      of these initiatives: increased awareness of fast food dangers, increased awareness to the
      dangers of nargillah smoking, and increased awareness as to the importance of physical
      activity.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Training of community members in leadership and community-based health promotion skills
primary purpose: Prevention
masking: None (Open Label)
measure: Program implementation
time frame: 12 months after completion of the course
description: Three programs will be implemented by the group within 12 months of initiation of the course.
measure: RE-AIM assessment of intervention quality
time frame: 12 months after completion of the course
description: The RE-AIM assessment tool assesses Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention programs. Each domain is assessed by questions adapted from the RE-AIM framework. Each item is scored as fully implemented, partially implemented or not implemented, with 0 as not, 0.5 as partially and 1.0 as fully, The questions for each item are averaged for a score that ranges from 0-1, with one being full implementation
measure: health promotion leadership self efficacy
time frame: upon completion of the course, approximately 14 weeks after initiating the intervention.
description: 13 item questionnaire with scores ranging from 13- 52, with 52 representing higher self efficacy
arm group label: Training community health promotion leaderss
arm group type: Experimental
description: Community women are trained in leadership and community-based health promotion skills
intervention type: Behavioral
intervention name: leadership empowerment
description: In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adapting a healthy life style, leadership and facilitation skills and the development, implementation and evaluation process required to conduct a community program that will impact society. Women learned how to map needs and resources, define goals and objectives, develop, implement and evaluate a community based program.
arm group label: Training community health promotion leaderss
criteria: 
gender: Female
gender based: Yes
gender description: As per self-identification
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donna Zwas, MD MPH
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Donna Zwas, MD MPH
phone: 972504048274
email: donnaz1818@gmail.com
last name: Rivka May, BS
phone: 972505406064
email: rivkatmay@hadassah.org.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
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
sharing ipd: No
ipd description: deidentified data may be shared upon reasonable investigator request