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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 : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity and health benefits in children and adolescents. The project will include 52 children and adolescents, between 12-18 years, who are not sufficiently active according to current guidelines (< 60 min daily moderate/vigorous activity) and report to play video games for more than 10 hours per week. The physical fitness (maximal oxygen consumption), blood markers of cardiometabolic health, body composition and objectively measured physical activity will be tested before, mid-ways and after the intervention period.

Also, the participants gaming frequency will be registered throughout the 24 week period. Aim of this study is to investigate if access to this game can provide health benefits for children and adolescents who are not motivated to take part in regular physical activity.


Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Exergaming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Physical Activity Among Adolescents With Motivational High-Intensity Training Through a Cutting-Edge Gaming Platform
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergaming
24 week access to the exergaming platform PlayPulse
Behavioral: Exergaming
free access to the exergaming platform PlayPulse for 24 weeks
Other Name: PlayPulse

No Intervention: Control
Asked to continue with their normal daily routine



Primary Outcome Measures :
  1. VO2max [ Time Frame: 12 weeks ]
    Maximal Aerobic Capacity

  2. VO2max [ Time Frame: 24 weeks ]
    Maximal Aerobic Capacity


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Bioelectrical impedance [ Time Frame: 12 and 24 weeks ]
    Body composition assessed using bioelectrical impedance analysis (InBody 720)

  9. systolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  10. Diastolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  11. Fasting circulating glucose, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  12. Lipid profile, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  13. Circulating insulin concentration, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  14. HbA1c from blood samples [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663699


Contacts
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Contact: Trine Moholdt, PhD +4797098594 trine.moholdt@ntnu.no
Contact: Jonathan Berg, MSc +4745205565 jonathan.berg@ntnu.no

Locations
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Norway
Department of Circulation and Medical Imaging Recruiting
Trondheim, Norway, 7491
Contact: Jonathan Berg, MSc    +47 45205565    jonathan.berg@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Director: Øystein Risa, PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03663699     History of Changes
Other Study ID Numbers: 2018/633
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Exercise Therapy
Physical Fitness
Games, Recreational
Children
Adolescents
Healthy Lifestyle
Exercise Test