<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/NCT01686399</url>
  </required_header>
  <id_info>
    <org_study_id>HMO 0645-11</org_study_id>
    <nct_id>NCT01686399</nct_id>
  </id_info>
  <brief_title>A Sustainable Diet for Hadassah Employees Workers</brief_title>
  <official_title>A Sustainable Diet for Hadassah Employees</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this protocol is to use a multidisciplinary approach to convey nutrition and&#xD;
      activity messages to randomly selected Hadassah Medical Center employees. The intervention&#xD;
      will be for one academic year and include frontal talks, email and internet focus group&#xD;
      interactions, public demonstrations and a focused intervention within the hospital kitchen.&#xD;
&#xD;
      The outcomes are specific parameters of dietary modifications, degree of physical activity&#xD;
      and health related perspectives. Outcomes will be recorded at baseline and by the end of the&#xD;
      intervention ( one year).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be selected randomly from the campus employees. They will be exposed to&#xD;
      multiple levels of health promotion at the work place as well as via multiple media tools.&#xD;
      Analysis will be performed at baseline by using multiple nutrition and health perception&#xD;
      questionnaires. A second group from the employees will be selected for assessment of the same&#xD;
      outcomes at the end of the year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in amount of fruit/vegetable consumption per day</measure>
    <time_frame>one year</time_frame>
    <description>Amount of fruit/vegetable consumption will be evaluated via questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of physical activity per week</measure>
    <time_frame>one year</time_frame>
    <description>Amount of physical activity will be assessed via questionnaires</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Amount of soft drinks consumed per day</measure>
    <time_frame>one year</time_frame>
    <description>The amount of soft drinks consumed per day will be assessed via questionnaires</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Obesity</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>The study has a single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional and Activity Promotion</intervention_name>
    <description>Multi disciplinary nutritional and behavioral messages to improve diet and activity levels</description>
    <arm_group_label>The study has a single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hadassah medical center employees Age 21-67&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ram Weiss, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dorit Adler, MPH</last_name>
    <phone>02677551</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem Region</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Dorit Adler, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>March 22, 2015</last_update_submitted>
  <last_update_submitted_qc>March 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Ram Weiss</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sustainable diet</keyword>
  <keyword>Health promotion</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686399
org study id: HMO 0645-11
nct id: NCT01686399
lead sponsor: 
has dmc: No
The aim of this protocol is to use a multidisciplinary approach to convey nutrition and
      activity messages to randomly selected Hadassah Medical Center employees. The intervention
      will be for one academic year and include frontal talks, email and internet focus group
      interactions, public demonstrations and a focused intervention within the hospital kitchen.

      The outcomes are specific parameters of dietary modifications, degree of physical activity
      and health related perspectives. Outcomes will be recorded at baseline and by the end of the
      intervention ( one year).
The participants will be selected randomly from the campus employees. They will be exposed to
      multiple levels of health promotion at the work place as well as via multiple media tools.
      Analysis will be performed at baseline by using multiple nutrition and health perception
      questionnaires. A second group from the employees will be selected for assessment of the same
      outcomes at the end of the year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in amount of fruit/vegetable consumption per day
time frame: one year
description: Amount of fruit/vegetable consumption will be evaluated via questionnaires
measure: Amount of physical activity per week
time frame: one year
description: Amount of physical activity will be assessed via questionnaires
measure: Amount of soft drinks consumed per day
time frame: one year
description: The amount of soft drinks consumed per day will be assessed via questionnaires
arm group label: The study has a single arm
arm group type: Experimental
description: The study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention
intervention type: Behavioral
intervention name: Nutritional and Activity Promotion
description: Multi disciplinary nutritional and behavioral messages to improve diet and activity levels
arm group label: The study has a single arm
criteria: 
gender: All
minimum age: 21 Years
maximum age: 67 Years
healthy volunteers: No
last name: Ram Weiss, MD PhD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Dorit Adler, MPH
phone: 02677551
facility: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Ram Weiss
investigator title: Associate Professor
mesh term: Obesity