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Gaming and Training Combined to Help Adolescents Get More Physically Active

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ClinicalTrials.gov Identifier: NCT03663699
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • VO2max [ Time Frame: 12 weeks ]
    Maximal Aerobic Capacity
  • VO2max [ Time Frame: 24 weeks ]
    Maximal Aerobic Capacity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Change in daily average energy expenditure [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily average total physical activity duration [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily average number of steps [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Bioelectrical impedance [ Time Frame: 12 and 24 weeks ]
    Body composition assessed using bioelectrical impedance analysis (InBody 720)
  • systolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  • Diastolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  • Fasting circulating glucose, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • Lipid profile, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • Circulating insulin concentration, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • HbA1c from blood samples [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Change in daily average energy expenditure [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily average total physical activity duration [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Change in daily average number of steps [ Time Frame: Baseline, 12 and 24 weeks ]
    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
  • Bioelectrical impedance [ Time Frame: 12 and 24 weeks ]
    Body composition assessed using bioelectrical impedance analysis (InBody 720)
  • Blood Pressure [ Time Frame: 12 and 24 weeks ]
  • Fasting circulating glucose, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • Lipid profile, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • Circulating insulin concentration, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  • Glucose response to a 2-hour glucose tolerance test, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gaming and Training Combined to Help Adolescents Get More Physically Active
Official Title  ICMJE Increasing Physical Activity Among Adolescents With Motivational High-Intensity Training Through a Cutting-Edge Gaming Platform
Brief Summary The purpose of this study is to investigate if playing a newly developed videogame that requires physical activity (e.g. exergame), leads to increased physical activity and health benefits in children and adolescents who do not regularly participate in endurance training. Health benefits will be expressed in physical fitness (maximal oxygen consumption), blood markers of a healthy heart, body composition and objectively measured physical activity. Gaming frequency of the participants will be registered throughout the 24 week intervention period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sedentary Lifestyle
Intervention  ICMJE Behavioral: Exergaming
free access to the exergaming platform PlayPulse for 24 weeks
Other Name: PlayPulse
Study Arms  ICMJE
  • Experimental: Exergaming
    24 week access to the exergaming platform PlayPulse
    Intervention: Behavioral: Exergaming
  • No Intervention: Control
    Asked to continue with their normal daily routine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
52
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Not regularly participating in endurance training
  • Sedentary (<60 mins daily moderate/vigorous intensity physical activity)
  • Play video games > 10 hours/week (self-reported)
  • Able to ride a bike for up to 60 minutes

Exclusion Criteria:

  • Known cardiovascular disease
  • Type I diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trine Moholdt, PhD +4797098594 trine.moholdt@ntnu.no
Contact: Jonathan Berg, MSc +4745205565 jonathan.berg@ntnu.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663699
Other Study ID Numbers  ICMJE 2018/633
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Øystein Risa, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP