<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/NCT03279497</url>
  </required_header>
  <id_info>
    <org_study_id>MoveF2017</org_study_id>
    <nct_id>NCT03279497</nct_id>
  </id_info>
  <brief_title>Health Game Intervention to Promote the Physical Activity of Early Adolescents</brief_title>
  <official_title>Health Game Intervention to Promote the Physical Activity of Early Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the effectiveness of the game-intervention in promotion of physical&#xD;
      activity self-efficacy and physical activity behavior among early adolescents (10-13 year&#xD;
      olds). Half of the study participants will receive the game-intervention and half of the&#xD;
      study participants will receive a commercially available sport and fitness application for&#xD;
      running, cycling and every-day training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study evaluates the effectiveness of the game-intervention in promotion of physical&#xD;
      activity self-efficacy and physical activity behavior among early 10 to 13 years old&#xD;
      adolescents. Participants allocated to the Health game intervention group will use a game&#xD;
      called Movenator, during a four week intervention and participants allocated to the Sport and&#xD;
      fitness-intervention group will use a commercially available Sport and fitness application&#xD;
      for running, cycling and every-day training, during a four week intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical activity behavior</measure>
    <time_frame>at baseline during one week period and at 4 weeks during one week period</time_frame>
    <description>Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Physical activity self-efficacy</measure>
    <time_frame>At baseline and at 4 weeks</time_frame>
    <description>Measured with Physical Activity Self-Efficacy Scale (PASES), a 8-item 5-point Likert-scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actual use of the intervention</measure>
    <time_frame>During the four week intervention</time_frame>
    <description>Actual use of the intervention is tracked with log files</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability of the intervention</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Physical Activity</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Health game</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health game intervention consists of 20 minutes guided training session with the mobile health game at school and 4 weeks free usage of the game via own smart phone during free time. Smart phones are tracking the actual physical activity (steps) of the participants via activity sensors and the tracked steps work as In-App Currency enabling the participants to play the game and proceed in it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sport and fitness application</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sport and fitness application intervention consists of 20 minutes guided training session with the app at school and 4 weeks free usage of the app via own smart phone during free time. Sport and fitness application, when turned on, tracks the physical activity (running, cycling and every-day training) of the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health game</intervention_name>
    <description>Participants allocated to the Health game intervention group get to use the health game during the four week intervention period and participants are allowed to use it on their free time.</description>
    <arm_group_label>Health game</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sport and fitness application</intervention_name>
    <description>Participants allocated to the Sport and fitness application intervention group get to use the sport and fitness application during the four week intervention period and participants are allowed to use it on their free time.</description>
    <arm_group_label>Sport and fitness application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Goes to school at 4th, 5th or 6th grade&#xD;
&#xD;
          -  Understands and can communicate either in Finnish&#xD;
&#xD;
          -  Has daily access to a smart phone (Android) during free time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical activity impairments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anni Pakarinen, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anni Pakarinen, MHSc</last_name>
    <phone>+358451213567</phone>
    <email>anni.pakarinen@utu.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>Primary schools (n=2)</name>
      <address>
        <city>Turku</city>
        <state>Southwest Finland</state>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anni Pakarinen</last_name>
      <phone>+358451213567</phone>
      <email>anni.pakarinen@utu.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Anni Pakarinen</investigator_full_name>
    <investigator_title>Doctoral candidate</investigator_title>
  </responsible_party>
  <!-- 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/NCT03279497
org study id: MoveF2017
nct id: NCT03279497
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study evaluates the effectiveness of the game-intervention in promotion of physical
      activity self-efficacy and physical activity behavior among early adolescents (10-13 year
      olds). Half of the study participants will receive the game-intervention and half of the
      study participants will receive a commercially available sport and fitness application for
      running, cycling and every-day training.
The study evaluates the effectiveness of the game-intervention in promotion of physical
      activity self-efficacy and physical activity behavior among early 10 to 13 years old
      adolescents. Participants allocated to the Health game intervention group will use a game
      called Movenator, during a four week intervention and participants allocated to the Sport and
      fitness-intervention group will use a commercially available Sport and fitness application
      for running, cycling and every-day training, during a four week intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in Physical activity behavior
time frame: at baseline during one week period and at 4 weeks during one week period
description: Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period
measure: Change in Physical activity self-efficacy
time frame: At baseline and at 4 weeks
description: Measured with Physical Activity Self-Efficacy Scale (PASES), a 8-item 5-point Likert-scale.
measure: Actual use of the intervention
time frame: During the four week intervention
description: Actual use of the intervention is tracked with log files
measure: Usability of the intervention
time frame: At 4 weeks
description: Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale
arm group label: Health game
arm group type: Experimental
description: Health game intervention consists of 20 minutes guided training session with the mobile health game at school and 4 weeks free usage of the game via own smart phone during free time. Smart phones are tracking the actual physical activity (steps) of the participants via activity sensors and the tracked steps work as In-App Currency enabling the participants to play the game and proceed in it.
arm group label: Sport and fitness application
arm group type: Sham Comparator
description: Sport and fitness application intervention consists of 20 minutes guided training session with the app at school and 4 weeks free usage of the app via own smart phone during free time. Sport and fitness application, when turned on, tracks the physical activity (running, cycling and every-day training) of the participant.
intervention type: Behavioral
intervention name: Health game
description: Participants allocated to the Health game intervention group get to use the health game during the four week intervention period and participants are allowed to use it on their free time.
arm group label: Health game
intervention type: Behavioral
intervention name: Sport and fitness application
description: Participants allocated to the Sport and fitness application intervention group get to use the sport and fitness application during the four week intervention period and participants are allowed to use it on their free time.
arm group label: Sport and fitness application
criteria: 
gender: All
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anni Pakarinen, MHSc
role: Principal Investigator
affiliation: University of Turku
last name: Anni Pakarinen, MHSc
phone: +358451213567
email: anni.pakarinen@utu.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Anni Pakarinen
investigator title: Doctoral candidate