<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/NCT01693926</url>
  </required_header>
  <id_info>
    <org_study_id>286/12</org_study_id>
    <nct_id>NCT01693926</nct_id>
  </id_info>
  <brief_title>Effect of Physical Activity an Stress in Children</brief_title>
  <official_title>Effect of Physical Activity an Stress in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the impact of physical activity in obese and&#xD;
      nonobese prepubertal children on:&#xD;
&#xD;
        1. biological stress responses during a psychosocial stress test&#xD;
&#xD;
        2. snacking and feeling of hunger in response to the same psychosocial stress test&#xD;
&#xD;
        3. the moderating factor of attachment on the biological stress responses and on snacking&#xD;
&#xD;
      Children will be investigated on one study day during 3.5 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses In this study, 3 primary hypotheses will be tested.&#xD;
&#xD;
        1. Moderate physical activity during 25 min in children decreases the cortisol levels in&#xD;
           response to the Trier Social Stress Test TSST-C (for children).&#xD;
&#xD;
        2. Moderate physical activity during 25 min in children decreases the snacking (calorie&#xD;
           consumption when corrected for expenditure and switch in quality of food intake) in&#xD;
           response to the Trier Social Stress Test TSST-C (for children).&#xD;
&#xD;
        3. A secure attachment will be a moderating factor for the general increase in cortisol and&#xD;
           the snacking in response to the psychosocial stress test (Trier Social Stress Test&#xD;
           TSST-C).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. To test if the impact of physical activity on stress responses and snacking differs&#xD;
           between obese and non-obese children&#xD;
&#xD;
        2. To test the impact of physical activity on the cardiovascular stress reactivity (blood&#xD;
           pressure, heart rate) and the perceived stress (scale) in response to the Trier Social&#xD;
           Stress Test TSST-C?&#xD;
&#xD;
        3. To test if the stress reactivity and its modulation by physical activity is different in&#xD;
           anxious and in impulsives/labile children&#xD;
&#xD;
        4. To test if serious life events and parental worries and parental educational style&#xD;
           influence the stress reactivity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Snacking (Caloric intake, corrected for energy expenditure)</measure>
    <time_frame>9 months</time_frame>
    <description>Measure of caloric intake and measure of choice of high-caloric vs low-caloric food snacking after the TSST stress test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Moderator effect of attachment (4 different attachment categories), i.e. children with a secure attachment will have lower rises in cortisol compared with children in the other 3 attachment categories</measure>
    <time_frame>9 months</time_frame>
    <description>Cortisol levels after the TSST stress test will be lower in children with secure attachment compared to detached, disorganized or preoccupied children (i.e. the 3 other attachment categories).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderator effect of obesity (WHO criteria)</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress (stress scale from 1-7)</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderator role of serious life events and parental worries</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Obesity</condition>
  <condition>Children</condition>
  <condition>Physical Activity</condition>
  <condition>Stress</condition>
  <condition>Snacking</condition>
  <arm_group>
    <arm_group_label>Acute physical activity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 min of moderate physical activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>25 min of reading (instead of physical activity)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acute physical activity intervention</intervention_name>
    <description>25 min of physical activity. The placebo arm will have 25 min of reading.</description>
    <arm_group_label>Acute physical activity intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  7-10 year old children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe illness&#xD;
&#xD;
          -  Medications interfering with study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Univeristy of Lausanne, SUPEA</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Jardena Puder</investigator_full_name>
    <investigator_title>Medin adjoint</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Children</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Stress</keyword>
  <keyword>Snacking</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/NCT01693926
org study id: 286/12
nct id: NCT01693926
lead sponsor: 
has dmc: No
The objective of the study is to evaluate the impact of physical activity in obese and
      nonobese prepubertal children on:

        1. biological stress responses during a psychosocial stress test

        2. snacking and feeling of hunger in response to the same psychosocial stress test

        3. the moderating factor of attachment on the biological stress responses and on snacking

      Children will be investigated on one study day during 3.5 hours.
Hypotheses In this study, 3 primary hypotheses will be tested.

        1. Moderate physical activity during 25 min in children decreases the cortisol levels in
           response to the Trier Social Stress Test TSST-C (for children).

        2. Moderate physical activity during 25 min in children decreases the snacking (calorie
           consumption when corrected for expenditure and switch in quality of food intake) in
           response to the Trier Social Stress Test TSST-C (for children).

        3. A secure attachment will be a moderating factor for the general increase in cortisol and
           the snacking in response to the psychosocial stress test (Trier Social Stress Test
           TSST-C).

      Secondary objectives:

        1. To test if the impact of physical activity on stress responses and snacking differs
           between obese and non-obese children

        2. To test the impact of physical activity on the cardiovascular stress reactivity (blood
           pressure, heart rate) and the perceived stress (scale) in response to the Trier Social
           Stress Test TSST-C?

        3. To test if the stress reactivity and its modulation by physical activity is different in
           anxious and in impulsives/labile children

        4. To test if serious life events and parental worries and parental educational style
           influence the stress reactivity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours
time frame: 9 months
measure: Snacking (Caloric intake, corrected for energy expenditure)
time frame: 9 months
description: Measure of caloric intake and measure of choice of high-caloric vs low-caloric food snacking after the TSST stress test
measure: Moderator effect of attachment (4 different attachment categories), i.e. children with a secure attachment will have lower rises in cortisol compared with children in the other 3 attachment categories
time frame: 9 months
description: Cortisol levels after the TSST stress test will be lower in children with secure attachment compared to detached, disorganized or preoccupied children (i.e. the 3 other attachment categories).
measure: Moderator effect of obesity (WHO criteria)
time frame: 9 months
measure: Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)
time frame: 9 months
measure: Perceived stress (stress scale from 1-7)
time frame: 9 months
measure: Moderator role of serious life events and parental worries
time frame: 9 months
arm group label: Acute physical activity intervention
arm group type: Experimental
description: 25 min of moderate physical activity
arm group label: Placebo
arm group type: Placebo Comparator
description: 25 min of reading (instead of physical activity)
intervention type: Behavioral
intervention name: Acute physical activity intervention
description: 25 min of physical activity. The placebo arm will have 25 min of reading.
arm group label: Acute physical activity intervention
intervention type: Behavioral
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Jardena Puder
investigator title: Medin adjoint
mesh term: Obesity