xml: <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/NCT05978869</url>
    </required_header>
    <id_info>
      <org_study_id>A-ER-106-441</org_study_id>
      <nct_id>NCT05978869</nct_id>
    </id_info>
    <brief_title>Gamified Fitness Training to Promote Children's Physical Activity</brief_title>
    <official_title>The Effectiveness of Gamified Fitness Training Integrated Into Health Education to Promote Children's Physical Activity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chi-Jane Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cheng-Kung University Hospital</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 aimed to introduce gamified physical fitness training in health education with the&#xD;
        goal of enhancing physical activity levels and assessing its feasibility within a small-scale&#xD;
        context involving 11-12-year-old children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A cluster experimental design was conducted in a small-scale context of school children.&#xD;
        Participants were recruited by inviting two elementary schools located in the same district&#xD;
        area for testing the physical fitness training effects. Two schools were randomly assigned to&#xD;
        either the training group (TG; n = 47) receiving physical fitness training or the control&#xD;
        group (CG; n = 44) without the training. Through a three-step process, gamified physical&#xD;
        fitness training was developed by a multidisciplinary team from the TG school. PA outcome&#xD;
        indicators were assessed using AI-wireless sensors attached to participants' wrists over 12&#xD;
        weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified&#xD;
        physical fitness training in health education classes. Data collection occurred during school&#xD;
        days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week&#xD;
        (T3). Generalized estimating equation statistics were used to assess the program effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 14, 2018</start_date>
    <completion_date type="Actual">December 15, 2018</completion_date>
    <primary_completion_date type="Actual">December 15, 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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>physical activity levels</measure>
      <time_frame>week 0</time_frame>
      <description>PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Learning Self-Efficacy</measure>
      <time_frame>week 0</time_frame>
      <description>Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>physical activity levels</measure>
      <time_frame>week 6</time_frame>
      <description>PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>physical activity levels</measure>
      <time_frame>week 12</time_frame>
      <description>PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Learning Self-Efficacy</measure>
      <time_frame>week 12</time_frame>
      <description>Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Satisfaction levels</measure>
      <time_frame>Week 12</time_frame>
      <description>For the satisfaction of the PA program, the evaluation was conducted at the 12-week, encompassing five aspects: the integration of physical training into the HE classes, the content of the physical training, the application of gamification strategies in training, the active play during class breaks, and the effectiveness of GHPT in improving PA. Responses to levels of satisfaction with the training program were assessed across five categories: very satisfied, satisfied, OK, dissatisfied, and extremely dissatisfied.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">91</enrollment>
    <condition>Physical Activity Levels</condition>
    <arm_group>
      <arm_group_label>physical fitness training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The training group received physical fitness training for 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No training group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The no training group did not receive any training program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical fitness training</intervention_name>
      <description>Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.</description>
      <arm_group_label>physical fitness training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  school children in 5th grade&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  physical deformity, mental disability, limited higher density physical activity such&#xD;
               as asthma, cardiovascular disease, and bone fracture.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chi-Jane Wang, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Nursing, College of Medicine, National Cheng Kung University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chi-Jane Wang</name>
        <address>
          <city>Tainan</city>
          <zip>701</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
      <investigator_full_name>Chi-Jane Wang</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978869
  org study id: A-ER-106-441
  nct id: NCT05978869
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aimed to introduce gamified physical fitness training in health education with the
        goal of enhancing physical activity levels and assessing its feasibility within a small-scale
        context involving 11-12-year-old children.
  A cluster experimental design was conducted in a small-scale context of school children.
        Participants were recruited by inviting two elementary schools located in the same district
        area for testing the physical fitness training effects. Two schools were randomly assigned to
        either the training group (TG; n = 47) receiving physical fitness training or the control
        group (CG; n = 44) without the training. Through a three-step process, gamified physical
        fitness training was developed by a multidisciplinary team from the TG school. PA outcome
        indicators were assessed using AI-wireless sensors attached to participants' wrists over 12
        weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified
        physical fitness training in health education classes. Data collection occurred during school
        days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week
        (T3). Generalized estimating equation statistics were used to assess the program effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: physical activity levels
  time frame: week 0
  description: PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
  measure: Learning Self-Efficacy
  time frame: week 0
  description: Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
  measure: physical activity levels
  time frame: week 6
  description: PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
  measure: physical activity levels
  time frame: week 12
  description: PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
  measure: Learning Self-Efficacy
  time frame: week 12
  description: Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
  measure: Satisfaction levels
  time frame: Week 12
  description: For the satisfaction of the PA program, the evaluation was conducted at the 12-week, encompassing five aspects: the integration of physical training into the HE classes, the content of the physical training, the application of gamification strategies in training, the active play during class breaks, and the effectiveness of GHPT in improving PA. Responses to levels of satisfaction with the training program were assessed across five categories: very satisfied, satisfied, OK, dissatisfied, and extremely dissatisfied.
  arm group label: physical fitness training
  arm group type: Experimental
  description: The training group received physical fitness training for 12 weeks
  arm group label: No training group
  arm group type: No Intervention
  description: The no training group did not receive any training program
  intervention type: Other
  intervention name: physical fitness training
  description: Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.
  arm group label: physical fitness training
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Chi-Jane Wang, Ph.D.
  role: Principal Investigator
  affiliation: Department of Nursing, College of Medicine, National Cheng Kung University
  facility: 
  country: Taiwan
  responsible party type: Sponsor-Investigator
  investigator affiliation: National Cheng-Kung University Hospital
  investigator full name: Chi-Jane Wang
  investigator title: Associate Professor
  sharing ipd: No