xml: <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/NCT06009328</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/003398</org_study_id>
      <nct_id>NCT06009328</nct_id>
    </id_info>
    <brief_title>Fundamental Movement Skills, Body Mass Index and Quality of Life in Children</brief_title>
    <official_title>Correlation Between Fundamental Movement Skills, Body Mass Index, and Quality of Life in School Aged Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        Early childhood obesity is a serious worldwide problem, and fundamental movement skills (FMS)&#xD;
        are very important factors in human movement. Thus, several advanced studies have examined&#xD;
        the associations between FMS, body mass index (BMI) and quality of life.&#xD;
  &#xD;
        The purpose of this study was to investigate the relation between FMS, BMI and quality of&#xD;
        life in Egyptian school aged children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 216 primary school aged children, aged 5-7 y from both sex participated in this&#xD;
        study. FMS were measured using the Test of Gross Motor Development-II (TGMD-II), and BMI was&#xD;
        calculated as the weight (kg) divided by the square of the height (m) [weight/ height2] ,and&#xD;
        quality of life was measured by PedsQol scale&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">September 11, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>test of gross motor development</measure>
      <time_frame>3 months</time_frame>
      <description>a valid and reliable test for assessing fundamental movement skills in children aged 3-10 years</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body mass index</measure>
      <time_frame>3 months</time_frame>
      <description>used to assess anthropometric measurements</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PedsQol scale</measure>
      <time_frame>3 months</time_frame>
      <description>used to assess quality of life in children. generic core scale will be used and total score will be used in analysis</description>
    </primary_outcome>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Overweight Children</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fundamental movement skills</intervention_name>
      <description>measured by test of gross motor development</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          normal school aged children from 5-8 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - normal school aged children , aged 5-7 years with different weight categories&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  children with visual or auditory problems or those who experienced surgery in their&#xD;
               lower limbs 1 year before study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Alaa F AL-Nemr, Phd</last_name>
      <phone>01003727467</phone>
      <email>alaaalnemr28@cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alaa f alnemr</last_name>
      <phone>01003727467</phone>
      <email>alaaalnemr28@cu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty Of Physical Therapy</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Faculty OP Therapy</last_name>
        <email>alaaalnemr28@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Alaa Fahmy Hassan Al Nemr</investigator_full_name>
      <investigator_title>lecturer in pediatric department, faculty of physical therapy</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009328
  org study id: P.T.REC/012/003398
  nct id: NCT06009328
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Early childhood obesity is a serious worldwide problem, and fundamental movement skills (FMS)
        are very important factors in human movement. Thus, several advanced studies have examined
        the associations between FMS, body mass index (BMI) and quality of life.
  
        The purpose of this study was to investigate the relation between FMS, BMI and quality of
        life in Egyptian school aged children.
  A total of 216 primary school aged children, aged 5-7 y from both sex participated in this
        study. FMS were measured using the Test of Gross Motor Development-II (TGMD-II), and BMI was
        calculated as the weight (kg) divided by the square of the height (m) [weight/ height2] ,and
        quality of life was measured by PedsQol scale
  observational model: Cohort
  time perspective: Prospective
  measure: test of gross motor development
  time frame: 3 months
  description: a valid and reliable test for assessing fundamental movement skills in children aged 3-10 years
  measure: body mass index
  time frame: 3 months
  description: used to assess anthropometric measurements
  measure: PedsQol scale
  time frame: 3 months
  description: used to assess quality of life in children. generic core scale will be used and total score will be used in analysis
  intervention type: Other
  intervention name: fundamental movement skills
  description: measured by test of gross motor development
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 7 Years
  last name: Alaa F AL-Nemr, Phd
  phone: 01003727467
  email: alaaalnemr28@cu.edu.eg
  last name: Alaa f alnemr
  phone: 01003727467
  email: alaaalnemr28@cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Alaa Fahmy Hassan Al Nemr
  investigator title: lecturer in pediatric department, faculty of physical therapy
  mesh term: Overweight