<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/NCT03018379</url>
  </required_header>
  <id_info>
    <org_study_id>RAF642</org_study_id>
    <nct_id>NCT03018379</nct_id>
  </id_info>
  <brief_title>Body Composition, Dietary Behaviors, Energy Expenditure and Physical Activity Among Moroccan Schoolchildren and Adolescents</brief_title>
  <official_title>Assessment Study of Body Composition, Energy Expenditure and Physical Activity to Inform Design and Improve Interventions for the Prevention and Control of Obesity and Related Health Risks Among Schoolchildren and Adolescent Aged 8 to 14 Years in Morocco</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre National De L'énergie, Des Sciences Et Techniques Nucléaires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of National Education, Morocco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ibn Tofail University, Morocco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Atomic Energy Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre National De L'énergie, Des Sciences Et Techniques Nucléaires</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering the increasing public health concern the obesity in Morocco, the aim of the&#xD;
      present study was to use isotope techniques to assess body fat, total energy expenditure and&#xD;
      physical activity to inform design and improve interventions for the prevention and control&#xD;
      of obesity and related health risks such as diabetes and elevated blood pressure among&#xD;
      children and adolescents. Specific objectives of the trial: 1. Determine the extent of&#xD;
      obesity and physical activity levels in children and adolescents to design effective&#xD;
      interventions in the school setting. 2.Propose alternative field based techniques for&#xD;
      assessing body composition and physical activity that could be used in largescale situation&#xD;
      assessments and in assessing interventions to address obesity and risk related health care. *&#xD;
      For body composition: BMI z-score, waist circumference, waist measurement at height. * For&#xD;
      physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the&#xD;
      development of obesity and related health risks in schoolchildren and adolescents. 4.&#xD;
      Collaborate with stakeholders (government, schools and / or colleges, communities and&#xD;
      development partners) in designing interventions to address obesity and health risks. 5. To&#xD;
      recommend to stakeholders the most effective interventions in schools to prevent and combat&#xD;
      obesity and health risks in children and adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of body composition using deuterium dilution technique</measure>
    <time_frame>1 year</time_frame>
    <description>Each participant provided a predose saliva sample. The postdose sample was collected from 3h to 4h after the administration of the dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of energy expenditure using isotopes dilution techniques</measure>
    <time_frame>1 year</time_frame>
    <description>Each participant provided a predose urine sample. The postdose urine samples were collected after 3h to 4h and on days 3, 7 and 14.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of physical activity levels using accelerometry triaxial (GT3X+)</measure>
    <time_frame>2 years 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of dietary intake using 24h recall questionnaire</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)</measure>
    <time_frame>2 years 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">432</enrollment>
  <condition>Body Composition</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Assessment of body composition</arm_group_label>
    <description>The collection of the samples and the analyses were undertaken according to the guidelines of the International Atomic Energy Agency. In brief, after having emptied the bladder, each participant provided a predose saliva sample using a cotton ball.A 99.8 % deuterium dose of 0.5 g per kg body weight was given orally to the participant. The postdose sample was collected from 3h to 4h after the administration of the dose. The saliva samples were stored at 20°C until analysis by Fourier transform infrared spectroscopy (FTIR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment of energy expenditure</arm_group_label>
    <description>Each participant provided a predose urine sample. A dose of doubly labelled water 2.625 ml per kg body weight was given orally to the participant.&#xD;
The post dose sample was collected at 3h to 4h , and on days 3, 7 and 14 after dosing. An aliquot of those samples were stored at 20°C in tightly sealed containers until analysis by isotope-ratio mass spectrometry (IRMS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment of physical activity</arm_group_label>
    <description>The participants were instructed to wear the accelerometer triaxial (GT3X+) attached to an elasticized belt around the waist, once they woke up until bed time at night for 7 consecutive days and to remove the accelerometer any time they were to perform activities that involve the use of water and when going to bed.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Moroccan children and adolescents recruited from public urban schools.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy&#xD;
&#xD;
          -  Aged between 8 to 14 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypo or hypervolemic conditions including diet&#xD;
&#xD;
          -  Diuretics and oedema&#xD;
&#xD;
          -  Private schools&#xD;
&#xD;
          -  Rural area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asmaa EL HAMDOUCHI, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre National De L'énergie, Des Sciences Et Techniques Nucléaires</investigator_affiliation>
    <investigator_full_name>Asmaa El Hamdouchi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Body composition</keyword>
  <keyword>energy expenditure</keyword>
  <keyword>sedentarity</keyword>
  <keyword>dietary behaviors</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/NCT03018379
org study id: RAF642
nct id: NCT03018379
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Considering the increasing public health concern the obesity in Morocco, the aim of the
      present study was to use isotope techniques to assess body fat, total energy expenditure and
      physical activity to inform design and improve interventions for the prevention and control
      of obesity and related health risks such as diabetes and elevated blood pressure among
      children and adolescents. Specific objectives of the trial: 1. Determine the extent of
      obesity and physical activity levels in children and adolescents to design effective
      interventions in the school setting. 2.Propose alternative field based techniques for
      assessing body composition and physical activity that could be used in largescale situation
      assessments and in assessing interventions to address obesity and risk related health care. *
      For body composition: BMI z-score, waist circumference, waist measurement at height. * For
      physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the
      development of obesity and related health risks in schoolchildren and adolescents. 4.
      Collaborate with stakeholders (government, schools and / or colleges, communities and
      development partners) in designing interventions to address obesity and health risks. 5. To
      recommend to stakeholders the most effective interventions in schools to prevent and combat
      obesity and health risks in children and adolescents.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of body composition using deuterium dilution technique
time frame: 1 year
description: Each participant provided a predose saliva sample. The postdose sample was collected from 3h to 4h after the administration of the dose.
measure: Assessment of energy expenditure using isotopes dilution techniques
time frame: 1 year
description: Each participant provided a predose urine sample. The postdose urine samples were collected after 3h to 4h and on days 3, 7 and 14.
measure: Assessment of physical activity levels using accelerometry triaxial (GT3X+)
time frame: 2 years 6 months
measure: Assessment of dietary intake using 24h recall questionnaire
time frame: 6 months
measure: Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)
time frame: 2 years 6 months
arm group label: Assessment of body composition
description: The collection of the samples and the analyses were undertaken according to the guidelines of the International Atomic Energy Agency. In brief, after having emptied the bladder, each participant provided a predose saliva sample using a cotton ball.A 99.8 % deuterium dose of 0.5 g per kg body weight was given orally to the participant. The postdose sample was collected from 3h to 4h after the administration of the dose. The saliva samples were stored at 20°C until analysis by Fourier transform infrared spectroscopy (FTIR).
arm group label: Assessment of energy expenditure
description: Each participant provided a predose urine sample. A dose of doubly labelled water 2.625 ml per kg body weight was given orally to the participant.
The post dose sample was collected at 3h to 4h , and on days 3, 7 and 14 after dosing. An aliquot of those samples were stored at 20°C in tightly sealed containers until analysis by isotope-ratio mass spectrometry (IRMS).
arm group label: Assessment of physical activity
description: The participants were instructed to wear the accelerometer triaxial (GT3X+) attached to an elasticized belt around the waist, once they woke up until bed time at night for 7 consecutive days and to remove the accelerometer any time they were to perform activities that involve the use of water and when going to bed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Asmaa EL HAMDOUCHI, Dr
role: Principal Investigator
affiliation: Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university
responsible party type: Principal Investigator
investigator affiliation: Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
investigator full name: Asmaa El Hamdouchi
investigator title: Principal Investigator