<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/NCT02214108</url>
  </required_header>
  <id_info>
    <org_study_id>protwii2013</org_study_id>
    <nct_id>NCT02214108</nct_id>
  </id_info>
  <brief_title>Effect of Physical Activity Through Interactive Video Games in Overweight Children</brief_title>
  <official_title>Effect of Physical Activity Trough Interactive Video Games in Overweight, Randomized, Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Pediatrico Albina de Patino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Pediatrico Albina de Patino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of interactive video game in management&#xD;
      of overweight in children. The investigators will evaluate the effect of product versus&#xD;
      standard physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. Child Overweight and obesity are a world public health problem, in low income&#xD;
      countries is more. One difficulty in the management is the poor adherence to physical&#xD;
      activity, some studies show that active video games could improve this.&#xD;
&#xD;
      Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on&#xD;
      fitness, anthropometry and adherence to treatment, as part of an intervention program for the&#xD;
      management of childhood obesity in children over 5 years of age with obesity Methodology: A&#xD;
      clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of&#xD;
      overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of&#xD;
      one hour of physical activity by an active video game, the other group (control group)&#xD;
      received 3 weekly sessions of one hour of physical activity by static exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</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 Body Mass Index</measure>
    <time_frame>one month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in weight</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in physical endurance</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variations in serum lipids</measure>
    <time_frame>1 month</time_frame>
    <description>Cholesterol, triglycerides.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Phisical activity with Nintendo Wii</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 hours of weekly of physical activity, divided in 1 hour interday with Nintendo WII. games applied: Wii Boxing, Wii Tennis; Wii Bowling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>phisical activity with phisiotherapist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3 hours of weekly physical activity, divided in 1 hour interday. applying cardiovascular and muscular endurance static exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nintendo Wii</intervention_name>
    <description>Tennis, box and bowling on Nintendo Wii, 3 hours per week.</description>
    <arm_group_label>Phisical activity with Nintendo Wii</arm_group_label>
    <other_name>active video games</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children aged 5-10 years with a diagnosis of overweight or obese (according to WHO&#xD;
             criteria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  overweight or obese due other disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppe Esteban Grandy Aranda, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Centro de Pediatria Albina Patino</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alicia Ribero Nogales, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro de Pediatria Albina Patino</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gerardo Weisstaub, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Nutrition and Technology of Food.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Center Albina Patino</name>
      <address>
        <city>Cochabamba</city>
        <zip>555</zip>
        <country>Bolivia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bolivia</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>March 3, 2016</last_update_submitted>
  <last_update_submitted_qc>March 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Pediatrico Albina de Patino</investigator_affiliation>
    <investigator_full_name>Giuseppe Grandy</investigator_full_name>
    <investigator_title>Medical head of Nutrition Center Albina Patino</investigator_title>
  </responsible_party>
  <keyword>BMI</keyword>
  <keyword>Obesity</keyword>
  <keyword>overweight</keyword>
  <keyword>child</keyword>
  <keyword>Physical activity</keyword>
  <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>


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/NCT02214108
org study id: protwii2013
nct id: NCT02214108
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effect of interactive video game in management
      of overweight in children. The investigators will evaluate the effect of product versus
      standard physical activity.
Background. Child Overweight and obesity are a world public health problem, in low income
      countries is more. One difficulty in the management is the poor adherence to physical
      activity, some studies show that active video games could improve this.

      Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on
      fitness, anthropometry and adherence to treatment, as part of an intervention program for the
      management of childhood obesity in children over 5 years of age with obesity Methodology: A
      clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of
      overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of
      one hour of physical activity by an active video game, the other group (control group)
      received 3 weekly sessions of one hour of physical activity by static exercises.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Body Mass Index
time frame: one month
measure: change in weight
time frame: one month
measure: change in physical endurance
time frame: one month
measure: variations in serum lipids
time frame: 1 month
description: Cholesterol, triglycerides.
arm group label: Phisical activity with Nintendo Wii
arm group type: Experimental
description: 3 hours of weekly of physical activity, divided in 1 hour interday with Nintendo WII. games applied: Wii Boxing, Wii Tennis; Wii Bowling
arm group label: phisical activity with phisiotherapist
arm group type: No Intervention
description: 3 hours of weekly physical activity, divided in 1 hour interday. applying cardiovascular and muscular endurance static exercises.
intervention type: Other
intervention name: Nintendo Wii
description: Tennis, box and bowling on Nintendo Wii, 3 hours per week.
arm group label: Phisical activity with Nintendo Wii
other name: active video games
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: No
last name: Giuseppe Esteban Grandy Aranda, MSc
role: Study Director
affiliation: Centro de Pediatria Albina Patino
last name: Alicia Ribero Nogales, MD
role: Principal Investigator
affiliation: Centro de Pediatria Albina Patino
last name: Gerardo Weisstaub, MSc
role: Study Chair
affiliation: Institute of Nutrition and Technology of Food.
facility: 
country: Bolivia
responsible party type: Principal Investigator
investigator affiliation: Centro Pediatrico Albina de Patino
investigator full name: Giuseppe Grandy
investigator title: Medical head of Nutrition Center Albina Patino
mesh term: Overweight