<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/NCT03040258</url>
  </required_header>
  <id_info>
    <org_study_id>NUT.NH.12</org_study_id>
    <nct_id>NCT03040258</nct_id>
  </id_info>
  <brief_title>Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study</brief_title>
  <official_title>Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity-Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluate the feasibility and effectiveness of a multi-component school-based intervention to&#xD;
      promote healthy eating and physical activity with school children ages 9 to 11 years in&#xD;
      Lebanon.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2008</start_date>
  <completion_date type="Actual">March 10, 2010</completion_date>
  <primary_completion_date type="Actual">March 10, 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge score</measure>
    <time_frame>One school year</time_frame>
    <description>Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dietary habits</measure>
    <time_frame>One school year</time_frame>
    <description>Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and -post assessment phases)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-efficacy score</measure>
    <time_frame>One school year</time_frame>
    <description>Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight status</measure>
    <time_frame>One school year</time_frame>
    <description>Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">374</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention group- Health-E-PALS-Pilot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group of students not receiving any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health-E-PALS-Pilot</intervention_name>
    <description>Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service</description>
    <arm_group_label>Intervention group- Health-E-PALS-Pilot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schoolchildren&#xD;
&#xD;
          -  Aged 9 to 11 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nahla Houalla, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American University of Beirut Medical Center</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>School-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03040258
org study id: NUT.NH.12
nct id: NCT03040258
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate the feasibility and effectiveness of a multi-component school-based intervention to
      promote healthy eating and physical activity with school children ages 9 to 11 years in
      Lebanon.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in knowledge score
time frame: One school year
description: Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases
measure: Change in dietary habits
time frame: One school year
description: Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and -post assessment phases)
measure: Change in self-efficacy score
time frame: One school year
description: Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases
measure: Change in body weight status
time frame: One school year
description: Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.
arm group label: Intervention group- Health-E-PALS-Pilot
arm group type: Experimental
description: Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.
arm group label: Control group
arm group type: No Intervention
description: Group of students not receiving any intervention
intervention type: Other
intervention name: Health-E-PALS-Pilot
description: Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
arm group label: Intervention group- Health-E-PALS-Pilot
criteria: 
gender: All
minimum age: 9 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nahla Houalla, PhD
role: Principal Investigator
affiliation: American University of Beirut Medical Center
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity
sharing ipd: No