<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/NCT04418713</url>
  </required_header>
  <id_info>
    <org_study_id>DEP2017-85194-P</org_study_id>
    <nct_id>NCT04418713</nct_id>
  </id_info>
  <brief_title>Active Videogames Against Obesity in Children</brief_title>
  <acronym>VIDEOACTIVO</acronym>
  <official_title>Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>No</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>
      Active video games are presented as an exercise option for children with little interest in&#xD;
      traditional sports. The main objectives of this study are:&#xD;
&#xD;
        1. To evaluate the effects of an active video game program on cardiometabolic risk in&#xD;
           overweight/obese children&#xD;
&#xD;
        2. to identify the effect of this intervention on physical fitness&#xD;
&#xD;
        3. to study possible changes in the sedentary lifestyles of children after the exercise&#xD;
           program.&#xD;
&#xD;
      This is a randomized crossover study, with 2 intervention periods of 9 months each, and a&#xD;
      3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight&#xD;
      or obese will be included and randomly assigned to one of the 2 homogeneous groups&#xD;
      (control-intervention). Both groups will receive education in healthy lifestyles, and the&#xD;
      intervention group will also follow a physical exercise program with active video games (3-4&#xD;
      days/week). The sessions will last between 30 and 45 minutes and will include different&#xD;
      moderate-vigorous aerobic activities and muscular strength exercises. Body composition,&#xD;
      physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and&#xD;
      markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST,&#xD;
      gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary&#xD;
      habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck&#xD;
      circumference, and pubertal development will be also assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood obesity is one of the main problems in developed societies, and entails enormous&#xD;
      expenditure for the National Health System. In addition, childhood obesity is strongly&#xD;
      associated with adult obesity and with all types of cardiovascular and metabolic pathologies.&#xD;
      Physical exercise has been shown to be the great non-pharmacological enemy of both childhood&#xD;
      and adult obesity, however sport practice and adherence to it is not easy in the&#xD;
      overweight/obese population. In this context, active video games are presented as an exercise&#xD;
      option for children with little interest in traditional sports. The main objectives of this&#xD;
      study are: (1) To evaluate the effects of an active video game program on cardiometabolic&#xD;
      risk in overweight/obese children; (2) to identify the effect of this intervention on&#xD;
      physical fitness and (3) to study possible changes in the sedentary lifestyles of children&#xD;
      after the exercise program.&#xD;
&#xD;
      This is a randomized crossover study, with 2 intervention periods of 9 months each, and a&#xD;
      3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight&#xD;
      or obese will be included and randomly assigned to one of the 2 homogeneous groups&#xD;
      (control-intervention). Both groups will receive education in healthy lifestyles, and the&#xD;
      intervention group will also follow a physical exercise program with active video games (3-4&#xD;
      days/week). The sessions will last between 30 and 45 minutes and will include different&#xD;
      moderate-vigorous aerobic activities and muscular strength exercises. Body composition,&#xD;
      physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and&#xD;
      markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST,&#xD;
      gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary&#xD;
      habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck&#xD;
      circumference, and pubertal development will be also assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry</measure>
    <time_frame>Change from baseline in fat mass at 6 months</time_frame>
    <description>Fat mass is measured by dual X-ray photon absorptiometry (DXA) using the software and pediatric reference values (Hologic Explorer, Hologic Corp., Software Latest Version, Waltham, MA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).</measure>
    <time_frame>Change from baseline in size at 6 months</time_frame>
    <description>Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)</measure>
    <time_frame>Change from baseline in weight at 6 months</time_frame>
    <description>Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.</measure>
    <time_frame>Change from baseline in waist and hip circumference at 6 months</time_frame>
    <description>The waist and hip circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in height jump during 6 months evaluated by countermovement jump test</measure>
    <time_frame>Change from baseline in countermovement jump at 6 months</time_frame>
    <description>Jump is measured by calculating flight height during countermoving jumps (CMJ) with a Kistler force platform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.</measure>
    <time_frame>Change from baseline in dynamometry at 6 months</time_frame>
    <description>Maximum manual pressure force measured by a manual dynamometry is performed with a Takei-Grip dynamometer (Espana-Romero, 2010) from 5 to 100 kg adjusting the grip to the optimal measure to develop the greatest strength as described for boys and girls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knee extension isometric strength during 6 months evaluated by a strain gage.</measure>
    <time_frame>Change from baseline in isometric knee extension strength at 6 months</time_frame>
    <description>The isometric maximum force of quadriceps extension is evaluated by means of a strain gage anchored firmly to the wall and connected to a specific interface (MuscleLab); the force exerted by the subject for 10 seconds is measured and the maximum peak force is recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test</measure>
    <time_frame>Change from baseline in cardiorespiratory fitness at 6 months</time_frame>
    <description>To assess cardiorespiratory resistance, a continuous progressive test will be carried out until exhaustion, with electrocardiographic control and breath-by-breath gas analysis to measure VO2max by a maximum test with gas analyzer (Oxycon Pro, Jaeger / Viasys, Germany).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the level of physical activity during 6 months evaluated by accelerometry.</measure>
    <time_frame>Change from baseline in physical activity at 6 months</time_frame>
    <description>Accelerometer measures diferent intensities of physical activity during 1 week before and after the training with videogames</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis</measure>
    <time_frame>Change from baseline in markers of inflammation at 6 months</time_frame>
    <description>to evaluated the biochemical analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systolic blood pressure during 6 months evaluated by sphygmomanometer</measure>
    <time_frame>Change from baseline in systolic blood preasure at 6 months</time_frame>
    <description>Systolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.</measure>
    <time_frame>Change from baseline in diastolic blood pressure at 6 months</time_frame>
    <description>Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition habits during 6 months evaluated by a questionnaire</measure>
    <time_frame>Change from baseline in nutrition habits at 6 months</time_frame>
    <description>A questionnaire are used, to evaluated the nutritional habits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pubertal development during 6 months evaluated by Tanner stages.</measure>
    <time_frame>Change from baseline in pubertal development at 6 months</time_frame>
    <description>An experienced physician directly evaluates pubertal development by participants' Tanner stages.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Physical Activity</condition>
  <condition>Sedentary Lifestyle</condition>
  <condition>Body Fat</condition>
  <arm_group>
    <arm_group_label>exercise group with active video-games</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exergaming exercise: A combination of traditional exercise and exercise through active video games performed 3 days a week for one hour during 7 months. As well, it will be including some session about nutritional advice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no physical intevention will be provided, but it will be included some sessions on nutritional advice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>active video-games</intervention_name>
    <description>An intervention with active video-games to increase physical activity and improve body composition</description>
    <arm_group_label>exercise group with active video-games</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with obesity and overweight&#xD;
&#xD;
          -  children with ages between 9-11 years old&#xD;
&#xD;
          -  children in tanner stage I ó II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  to take drugs that can affect the measurements&#xD;
&#xD;
          -  menarche in girls&#xD;
&#xD;
          -  contraindications or pathologies associated with exercise&#xD;
&#xD;
          -  regular attendance at extracurricular activities of high energy expenditure&#xD;
&#xD;
          -  diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>José Antonio Casajús Mallén, PhD MD</last_name>
    <phone>876553755</phone>
    <phone_ext>+34</phone_ext>
    <email>joseant@unizar.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>José Antonio Casajús Mallén</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Antonio Casajús Mallén, PhD MD</last_name>
      <phone>876553755</phone>
      <phone_ext>+34</phone_ext>
      <email>joseant@unizar.es</email>
    </contact>
    <investigator>
      <last_name>José Antonio Casajús Mallén</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alejandro González de Agüero Lafuente</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 13, 2019</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>José A. Casajús</investigator_full_name>
    <investigator_title>Bachelor of Medicine, Specialist in Sports Medicine and University Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Sedentary Lifestyle</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Childhood Obesity</keyword>
  <keyword>Exergames</keyword>
  <keyword>Body Composition</keyword>
  <keyword>Physical Fitness</keyword>
  <keyword>Cardiometabolic Risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT04418713
org study id: DEP2017-85194-P
nct id: NCT04418713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Active video games are presented as an exercise option for children with little interest in
      traditional sports. The main objectives of this study are:

        1. To evaluate the effects of an active video game program on cardiometabolic risk in
           overweight/obese children

        2. to identify the effect of this intervention on physical fitness

        3. to study possible changes in the sedentary lifestyles of children after the exercise
           program.

      This is a randomized crossover study, with 2 intervention periods of 9 months each, and a
      3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight
      or obese will be included and randomly assigned to one of the 2 homogeneous groups
      (control-intervention). Both groups will receive education in healthy lifestyles, and the
      intervention group will also follow a physical exercise program with active video games (3-4
      days/week). The sessions will last between 30 and 45 minutes and will include different
      moderate-vigorous aerobic activities and muscular strength exercises. Body composition,
      physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and
      markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST,
      gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary
      habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck
      circumference, and pubertal development will be also assessed.
Childhood obesity is one of the main problems in developed societies, and entails enormous
      expenditure for the National Health System. In addition, childhood obesity is strongly
      associated with adult obesity and with all types of cardiovascular and metabolic pathologies.
      Physical exercise has been shown to be the great non-pharmacological enemy of both childhood
      and adult obesity, however sport practice and adherence to it is not easy in the
      overweight/obese population. In this context, active video games are presented as an exercise
      option for children with little interest in traditional sports. The main objectives of this
      study are: (1) To evaluate the effects of an active video game program on cardiometabolic
      risk in overweight/obese children; (2) to identify the effect of this intervention on
      physical fitness and (3) to study possible changes in the sedentary lifestyles of children
      after the exercise program.

      This is a randomized crossover study, with 2 intervention periods of 9 months each, and a
      3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight
      or obese will be included and randomly assigned to one of the 2 homogeneous groups
      (control-intervention). Both groups will receive education in healthy lifestyles, and the
      intervention group will also follow a physical exercise program with active video games (3-4
      days/week). The sessions will last between 30 and 45 minutes and will include different
      moderate-vigorous aerobic activities and muscular strength exercises. Body composition,
      physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and
      markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST,
      gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary
      habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck
      circumference, and pubertal development will be also assessed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry
time frame: Change from baseline in fat mass at 6 months
description: Fat mass is measured by dual X-ray photon absorptiometry (DXA) using the software and pediatric reference values (Hologic Explorer, Hologic Corp., Software Latest Version, Waltham, MA).
measure: Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).
time frame: Change from baseline in size at 6 months
description: Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),
measure: Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
time frame: Change from baseline in weight at 6 months
description: Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
measure: Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.
time frame: Change from baseline in waist and hip circumference at 6 months
description: The waist and hip circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).
measure: Change in height jump during 6 months evaluated by countermovement jump test
time frame: Change from baseline in countermovement jump at 6 months
description: Jump is measured by calculating flight height during countermoving jumps (CMJ) with a Kistler force platform.
measure: Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.
time frame: Change from baseline in dynamometry at 6 months
description: Maximum manual pressure force measured by a manual dynamometry is performed with a Takei-Grip dynamometer (Espana-Romero, 2010) from 5 to 100 kg adjusting the grip to the optimal measure to develop the greatest strength as described for boys and girls
measure: Change in knee extension isometric strength during 6 months evaluated by a strain gage.
time frame: Change from baseline in isometric knee extension strength at 6 months
description: The isometric maximum force of quadriceps extension is evaluated by means of a strain gage anchored firmly to the wall and connected to a specific interface (MuscleLab); the force exerted by the subject for 10 seconds is measured and the maximum peak force is recorded.
measure: Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test
time frame: Change from baseline in cardiorespiratory fitness at 6 months
description: To assess cardiorespiratory resistance, a continuous progressive test will be carried out until exhaustion, with electrocardiographic control and breath-by-breath gas analysis to measure VO2max by a maximum test with gas analyzer (Oxycon Pro, Jaeger / Viasys, Germany).
measure: Change in the level of physical activity during 6 months evaluated by accelerometry.
time frame: Change from baseline in physical activity at 6 months
description: Accelerometer measures diferent intensities of physical activity during 1 week before and after the training with videogames
measure: Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis
time frame: Change from baseline in markers of inflammation at 6 months
description: to evaluated the biochemical analysis
measure: Change in systolic blood pressure during 6 months evaluated by sphygmomanometer
time frame: Change from baseline in systolic blood preasure at 6 months
description: Systolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).
measure: Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.
time frame: Change from baseline in diastolic blood pressure at 6 months
description: Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).
measure: Change in nutrition habits during 6 months evaluated by a questionnaire
time frame: Change from baseline in nutrition habits at 6 months
description: A questionnaire are used, to evaluated the nutritional habits
measure: Change in pubertal development during 6 months evaluated by Tanner stages.
time frame: Change from baseline in pubertal development at 6 months
description: An experienced physician directly evaluates pubertal development by participants' Tanner stages.
arm group label: exercise group with active video-games
arm group type: Experimental
description: exergaming exercise: A combination of traditional exercise and exercise through active video games performed 3 days a week for one hour during 7 months. As well, it will be including some session about nutritional advice.
arm group label: control group
arm group type: No Intervention
description: no physical intevention will be provided, but it will be included some sessions on nutritional advice.
intervention type: Other
intervention name: active video-games
description: An intervention with active video-games to increase physical activity and improve body composition
arm group label: exercise group with active video-games
criteria: 
gender: All
minimum age: 9 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: José Antonio Casajús Mallén, PhD MD
phone: 876553755
phone ext: +34
email: joseant@unizar.es
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: José A. Casajús
investigator title: Bachelor of Medicine, Specialist in Sports Medicine and University Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No