<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/NCT04470960</url>
  </required_header>
  <id_info>
    <org_study_id>ccproject-HMO-CTIL</org_study_id>
    <nct_id>NCT04470960</nct_id>
  </id_info>
  <brief_title>Evaluation of a Health Promoting Community Center Network (HPCCN) Innovation.</brief_title>
  <acronym>HPCCN</acronym>
  <official_title>Evaluation of a Health Promoting Community Center Network (HPCCN) Innovation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Israel</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>
      The purpose of this research study is to design, implement and evaluate the setting for a&#xD;
      &quot;Healthy Community Center&quot;. This is a program review of a program which will be planned in a&#xD;
      community based participatory level, based on the socioecological model. A pre-post design&#xD;
      will be utilized where all community centers in the study will be exposed to the intervention&#xD;
      components. It is hypothesized that community centers who will receive the intervention will&#xD;
      have better skills at building sustainable participatory effective health promotion projects&#xD;
      and will provide a healthy setting for the community within its juristiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to design, implement and evaluate the setting for a&#xD;
      &quot;Healthy Community Center&quot;. This is a program review of a program which will be planned in a&#xD;
      community based participatory level, based on the socioecological model. A pre-post design&#xD;
      will be utilized where all community centers in the study will be exposed to the intervention&#xD;
      components. All community centers (n=15) will be evaluated by pre intervention questionairres&#xD;
      and focus groups of community center Managers and health promotion professionals. The network&#xD;
      will be designed upon the foundation of the &quot;Healthy Cities network&quot; with adaptations made in&#xD;
      the process of participatory planning and designing according to the results of the focus&#xD;
      groups. Intervention will include a a 12 week training session for designated &quot;Health&#xD;
      Coordinator&quot; from each community center, Planning and implementing a personolized Health&#xD;
      promtion Project in each community centre .It is hypothesized that community centers who will&#xD;
      receive the intervention will have better skills at building sustainable participatory&#xD;
      effective health promotion projects and will provide a healthy setting for the community&#xD;
      within its juristiction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2017</start_date>
  <completion_date type="Actual">November 24, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>A framework is being evaluated in order to assess if a Community center has the capacity of serving as a healthy setting.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>project planning, implementation and assessment</measure>
    <time_frame>3 years</time_frame>
    <description>RE-AIM assessment of Reach, Effectiveness, Adoption, Implementation and Maintenance of the Community Center Programs, assessed by interview, There are 4-6 tailored questions in each domain and the answers are coded as yes, partially and no. Scores range from 0 -93</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Israeli Healthy Cities Network adapted measure</measure>
    <time_frame>12 months after intervention initiation</time_frame>
    <description>Israeli Healthy Cities Network evaluation tool was designed based on the MARI's (Monitoring Accountability Reporting Impact assessment) framework. It assesses six dimensions of the principles and strategies of the Healthy Cities work: (i) Equity policy and political support. (ii) Management. (iii) Health promotion programs and activities in the city. (iv) Community participation. (v) Intersectoral partnerships (vi) Environmental protection activities. This questionnaire was adapted to a community center framework.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>European Quality Instrument for Health Promotion</measure>
    <time_frame>6 months after intervention initiation</time_frame>
    <description>information on four domains using in-person interviews: (i) compliance with international principles of Health promotion programs, (ii) development and implementation, (iii) project management and (iv) sustainability of programs. each item of the EQUIHP tool was recoded on a scale of 0-1: a score of 0 if the criteria was identified as not fulfilled, 0.5 if partly fulfilled and 1 if fully fulfilled. The sum of all valid scores per programme was divided by the number of valid answers to give the mean score. A mean score was given for each of the four domains, and for the overall score in the same manner. Higher scores are better.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>A Community Center as a Health Promoting Setting</condition>
  <arm_group>
    <arm_group_label>participating community centers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training course for the community center health coordinators Professional guidance for the CC health coordinators</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training course for the community center health coordinators</intervention_name>
    <description>These community centers who have volunteered to join the project will receive a 12 week training session which includes the values and principles of health promotion and the principles of building a health promotion project.&#xD;
The participants will be requested to build a health promotion project within their community. Building and implementing the project will be assisted by a health promotion specialist. Each health promotion project will be evaluated according to the principles of health promotion.</description>
    <arm_group_label>participating community centers</arm_group_label>
    <other_name>Professional guidance for the CC health coordinators</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People who live within the geographical area of the community centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children under the age of 6 People who do not reside within the geographical area of&#xD;
             the community centers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>March 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</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 The Linda Joy Pollin Womens Cardiovascular wellness Center</investigator_title>
  </responsible_party>
  <keyword>Community Centre</keyword>
  <keyword>Healthy setting</keyword>
  <keyword>Health promotion</keyword>
  <keyword>framework formation</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/NCT04470960
org study id: ccproject-HMO-CTIL
nct id: NCT04470960
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to design, implement and evaluate the setting for a
      "Healthy Community Center". This is a program review of a program which will be planned in a
      community based participatory level, based on the socioecological model. A pre-post design
      will be utilized where all community centers in the study will be exposed to the intervention
      components. It is hypothesized that community centers who will receive the intervention will
      have better skills at building sustainable participatory effective health promotion projects
      and will provide a healthy setting for the community within its juristiction.
The purpose of this research study is to design, implement and evaluate the setting for a
      "Healthy Community Center". This is a program review of a program which will be planned in a
      community based participatory level, based on the socioecological model. A pre-post design
      will be utilized where all community centers in the study will be exposed to the intervention
      components. All community centers (n=15) will be evaluated by pre intervention questionairres
      and focus groups of community center Managers and health promotion professionals. The network
      will be designed upon the foundation of the "Healthy Cities network" with adaptations made in
      the process of participatory planning and designing according to the results of the focus
      groups. Intervention will include a a 12 week training session for designated "Health
      Coordinator" from each community center, Planning and implementing a personolized Health
      promtion Project in each community centre .It is hypothesized that community centers who will
      receive the intervention will have better skills at building sustainable participatory
      effective health promotion projects and will provide a healthy setting for the community
      within its juristiction.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A framework is being evaluated in order to assess if a Community center has the capacity of serving as a healthy setting.
primary purpose: Prevention
masking: None (Open Label)
measure: project planning, implementation and assessment
time frame: 3 years
description: RE-AIM assessment of Reach, Effectiveness, Adoption, Implementation and Maintenance of the Community Center Programs, assessed by interview, There are 4-6 tailored questions in each domain and the answers are coded as yes, partially and no. Scores range from 0 -93
measure: Israeli Healthy Cities Network adapted measure
time frame: 12 months after intervention initiation
description: Israeli Healthy Cities Network evaluation tool was designed based on the MARI's (Monitoring Accountability Reporting Impact assessment) framework. It assesses six dimensions of the principles and strategies of the Healthy Cities work: (i) Equity policy and political support. (ii) Management. (iii) Health promotion programs and activities in the city. (iv) Community participation. (v) Intersectoral partnerships (vi) Environmental protection activities. This questionnaire was adapted to a community center framework.
measure: European Quality Instrument for Health Promotion
time frame: 6 months after intervention initiation
description: information on four domains using in-person interviews: (i) compliance with international principles of Health promotion programs, (ii) development and implementation, (iii) project management and (iv) sustainability of programs. each item of the EQUIHP tool was recoded on a scale of 0-1: a score of 0 if the criteria was identified as not fulfilled, 0.5 if partly fulfilled and 1 if fully fulfilled. The sum of all valid scores per programme was divided by the number of valid answers to give the mean score. A mean score was given for each of the four domains, and for the overall score in the same manner. Higher scores are better.
arm group label: participating community centers
arm group type: Experimental
description: Training course for the community center health coordinators Professional guidance for the CC health coordinators
intervention type: Behavioral
intervention name: Training course for the community center health coordinators
description: These community centers who have volunteered to join the project will receive a 12 week training session which includes the values and principles of health promotion and the principles of building a health promotion project.
The participants will be requested to build a health promotion project within their community. Building and implementing the project will be assisted by a health promotion specialist. Each health promotion project will be evaluated according to the principles of health promotion.
arm group label: participating community centers
other name: Professional guidance for the CC health coordinators
criteria: 
gender: Female
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Donna R Zwas
investigator title: Director of The Linda Joy Pollin Womens Cardiovascular wellness Center