<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/NCT02199119</url>
  </required_header>
  <id_info>
    <org_study_id>REB 2013-120</org_study_id>
    <nct_id>NCT02199119</nct_id>
  </id_info>
  <brief_title>Effect of Television Viewing and Exercise on Appetite, Satiety, and Food Intake in Children</brief_title>
  <official_title>Effect of Television Viewing During Exercise on Subjective Appetite, Satiation, and Food Intake in 9 to 14 Year Old Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toronto Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to describe the effect of 30 min TV viewing with or without&#xD;
      simultaneous moderate exercise using a treadmill on subsequent subjective appetite,&#xD;
      satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized&#xD;
      that TV viewing during exercise immediately before mealtime affects food intake regulation&#xD;
      through its effect on the control of appetite and satiation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food Intake kcal</measure>
    <time_frame>30 min after end of treatment</time_frame>
    <description>food is weighed pre and post consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite and satiation in mm</measure>
    <time_frame>measured at time 0, 15, 30, and 60 min</time_frame>
    <description>Subjective appetite determined by visual analogue scale</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitting quietly for 30 min No TV No exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TV viewing only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>watching TV for 30 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercising for 30 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TV viewing and Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 min of moderate exercise on a treadmill while watching TV</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>30 min of moderate exercise on a treadmill</description>
    <arm_group_label>Exercise only</arm_group_label>
    <arm_group_label>TV viewing and Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TV viewing</intervention_name>
    <description>watching TV (animated children's programming) for 30 min</description>
    <arm_group_label>TV viewing and Exercise</arm_group_label>
    <arm_group_label>TV viewing only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting quietly</intervention_name>
    <description>Sitting quietly for 30 min</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  overall healthy, normal weight (between the 5th and 85th BMI percentile for age and&#xD;
             gender) 9 to 14 year old boys and girls (peripubertal) born at term and at a normal&#xD;
             birth weight, and does not receive any medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant learning, behavioral, or emotional difficulties, restricted diet, food&#xD;
             allergies to test treatments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Bellissimo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto Metropolitan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FIRST Lab, Ryerson University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Toronto Metropolitan University</investigator_affiliation>
    <investigator_full_name>Nick Bellissimo</investigator_full_name>
    <investigator_title>Assistant Professor and Director, Food Intake Regulation &amp; Satiety</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>television</keyword>
  <keyword>exercise</keyword>
  <keyword>food intake</keyword>
  <keyword>appetite</keyword>
  <keyword>satiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric 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/NCT02199119
org study id: REB 2013-120
nct id: NCT02199119
lead sponsor: 
has dmc: No
The purpose of this study was to describe the effect of 30 min TV viewing with or without
      simultaneous moderate exercise using a treadmill on subsequent subjective appetite,
      satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized
      that TV viewing during exercise immediately before mealtime affects food intake regulation
      through its effect on the control of appetite and satiation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Food Intake kcal
time frame: 30 min after end of treatment
description: food is weighed pre and post consumption
measure: Subjective appetite and satiation in mm
time frame: measured at time 0, 15, 30, and 60 min
description: Subjective appetite determined by visual analogue scale
arm group label: Control
arm group type: Experimental
description: Sitting quietly for 30 min No TV No exercise
arm group label: TV viewing only
arm group type: Experimental
description: watching TV for 30 min
arm group label: Exercise only
arm group type: Experimental
description: exercising for 30 min
arm group label: TV viewing and Exercise
arm group type: Experimental
description: 30 min of moderate exercise on a treadmill while watching TV
intervention type: Behavioral
intervention name: Exercise
description: 30 min of moderate exercise on a treadmill
arm group label: Exercise only
arm group label: TV viewing and Exercise
intervention type: Behavioral
intervention name: TV viewing
description: watching TV (animated children's programming) for 30 min
arm group label: TV viewing and Exercise
arm group label: TV viewing only
intervention type: Behavioral
intervention name: Sitting quietly
description: Sitting quietly for 30 min
arm group label: Control
criteria: 
gender: All
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nick Bellissimo, PhD
role: Principal Investigator
affiliation: Toronto Metropolitan University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Toronto Metropolitan University
investigator full name: Nick Bellissimo
investigator title: Assistant Professor and Director, Food Intake Regulation & Satiety
mesh term: Pediatric Obesity