<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/NCT03027570</url>
  </required_header>
  <id_info>
    <org_study_id>0067-16-BBL</org_study_id>
    <nct_id>NCT03027570</nct_id>
  </id_info>
  <brief_title>The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children</brief_title>
  <official_title>The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bait Balev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bait Balev Hospital</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>
      80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of&#xD;
      overweight children.The intervention group will use the app &quot;Just Dance Now&quot; and The control&#xD;
      group will be exposed to the usual program without the app. Measurements will be performed at&#xD;
      the beginning of the program, the end and 3 months after completion of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers&#xD;
      for the treatment of overweight children. The intervention group will use the app &quot;Just Dance&#xD;
      Now&quot; and part of a weekly exercise session will be dedicated to a group app activity. The&#xD;
      control group will be exposed to the usual program without the app.&#xD;
&#xD;
      Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and&#xD;
      questionnaires regarding attitude and response to physical activity will be performed at the&#xD;
      beginning of the program, the end and 3 months after completion of the intervention.&#xD;
      Participation in the sessions will be documented and home activity recorded using a weekly&#xD;
      log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 6, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Body Mass index (BMI) score</measure>
    <time_frame>5-8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Behavioral Regulation in Exercise</measure>
    <time_frame>5-8 months</time_frame>
    <description>Determined using an Exercise regulation questionnaire (BREQ-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical Self-Perception Profile</measure>
    <time_frame>5-8 months</time_frame>
    <description>Determined using a Physical Self-Perception Profile questionnaire (PSPP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Response toward home physical activity</measure>
    <time_frame>5-8 months</time_frame>
    <description>By filling a weekly activity log.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Response toward physical activity sessions</measure>
    <time_frame>5-8 months</time_frame>
    <description>By filling physical activity session attendance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Level of physical activity</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using a Physical Activity Questionnaire - for elementary School (PAQ-C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sugar profile</measure>
    <time_frame>5-8 months</time_frame>
    <description>By measuring levels of HBAa1c and fasting glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipid profile</measure>
    <time_frame>5-8 months</time_frame>
    <description>By measuring levels of ADL, HDL, and Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic capacity</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using Modified YO-YO IR1 field test to estimate VO2Max levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed and Agility</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using 10*4 - Shuttle Run field test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg endurance ability</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using Wall Sit up field test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb explosive power</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using Standing Long Jump field test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forearm muscle strength</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using a hand grip failed test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coordination levels</measure>
    <time_frame>5-8 months</time_frame>
    <description>By using Modified Alternate Hand Wall Toss filed Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Body Mass Index</condition>
  <condition>Blood; Sugar, High</condition>
  <condition>Lipid Disorder</condition>
  <condition>Body Image</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five-month program at two centers for the treatment of overweight children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exergame activity_EXG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adding an exergame activity application to the regimen at a center for the treatment of overweight children.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exergame activity_EXG</intervention_name>
    <description>In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app &quot;Just Dance Now&quot; and part of a weekly exercise session will include a group activity with the app.</description>
    <arm_group_label>Exergame activity_EXG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Application activity</intervention_name>
    <description>The application - &quot;Just Dance Now&quot; will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.</description>
    <arm_group_label>Exergame activity_EXG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 5-13 from the center for the treatment of overweight children in the&#xD;
             MACABI health organization&#xD;
&#xD;
          -  BMI≥85%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with physical disabilities, that don't allow participation in physical&#xD;
             activity during the study.&#xD;
&#xD;
          -  Children who don't own a mobile phone or don't have an access to a computer to&#xD;
             activate the app for one hour a day.&#xD;
&#xD;
          -  BMI&lt;85%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shai Kremer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maccabi health organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centers for the treatment of overweight children - MACCABI health organization</name>
      <address>
        <city>Beer sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exergame</keyword>
  <keyword>Cellular apps</keyword>
  <keyword>Smartphone</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Children</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Fitness</keyword>
  <keyword>Motivation</keyword>
  <keyword>BMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03027570
org study id: 0067-16-BBL
nct id: NCT03027570
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of
      overweight children.The intervention group will use the app "Just Dance Now" and The control
      group will be exposed to the usual program without the app. Measurements will be performed at
      the beginning of the program, the end and 3 months after completion of the intervention.
80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers
      for the treatment of overweight children. The intervention group will use the app "Just Dance
      Now" and part of a weekly exercise session will be dedicated to a group app activity. The
      control group will be exposed to the usual program without the app.

      Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and
      questionnaires regarding attitude and response to physical activity will be performed at the
      beginning of the program, the end and 3 months after completion of the intervention.
      Participation in the sessions will be documented and home activity recorded using a weekly
      log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Changes in Body Mass index (BMI) score
time frame: 5-8 months
measure: Changes in Behavioral Regulation in Exercise
time frame: 5-8 months
description: Determined using an Exercise regulation questionnaire (BREQ-2)
measure: Changes in Physical Self-Perception Profile
time frame: 5-8 months
description: Determined using a Physical Self-Perception Profile questionnaire (PSPP).
measure: Changes in Response toward home physical activity
time frame: 5-8 months
description: By filling a weekly activity log.
measure: Changes in Response toward physical activity sessions
time frame: 5-8 months
description: By filling physical activity session attendance.
measure: Changes in Level of physical activity
time frame: 5-8 months
description: By using a Physical Activity Questionnaire - for elementary School (PAQ-C).
measure: Blood sugar profile
time frame: 5-8 months
description: By measuring levels of HBAa1c and fasting glucose.
measure: Blood lipid profile
time frame: 5-8 months
description: By measuring levels of ADL, HDL, and Triglycerides.
measure: Aerobic capacity
time frame: 5-8 months
description: By using Modified YO-YO IR1 field test to estimate VO2Max levels.
measure: Speed and Agility
time frame: 5-8 months
description: By using 10*4 - Shuttle Run field test.
measure: Leg endurance ability
time frame: 5-8 months
description: By using Wall Sit up field test.
measure: Lower limb explosive power
time frame: 5-8 months
description: By using Standing Long Jump field test.
measure: Forearm muscle strength
time frame: 5-8 months
description: By using a hand grip failed test.
measure: Coordination levels
time frame: 5-8 months
description: By using Modified Alternate Hand Wall Toss filed Test
arm group label: Control
arm group type: Experimental
description: Five-month program at two centers for the treatment of overweight children.
arm group label: Exergame activity_EXG
arm group type: Experimental
description: Adding an exergame activity application to the regimen at a center for the treatment of overweight children.
intervention type: Behavioral
intervention name: Control
description: Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.
arm group label: Control
intervention type: Behavioral
intervention name: Exergame activity_EXG
description: In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app "Just Dance Now" and part of a weekly exercise session will include a group activity with the app.
arm group label: Exergame activity_EXG
intervention type: Other
intervention name: Application activity
description: The application - "Just Dance Now" will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.
arm group label: Exergame activity_EXG
criteria: 
gender: All
minimum age: 5 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shai Kremer, MD
role: Principal Investigator
affiliation: Maccabi health organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Overweight
mesh term: Lipid Metabolism Disorders
mesh term: Hyperglycemia
sharing ipd: No