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Health Game Intervention to Promote the Physical Activity of Early Adolescents

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ClinicalTrials.gov Identifier: NCT03279497
Recruitment Status : Unknown
Verified October 2017 by Anni Pakarinen, University of Turku.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Anni Pakarinen, University of Turku

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date October 26, 2017
Estimated Study Start Date  ICMJE October 2017
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Change in Physical activity behavior [ Time Frame: at baseline during one week period and at 4 weeks during one week period ]
Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Change in Physical activity self-efficacy [ Time Frame: At baseline and at 4 weeks ]
    Measured with Physical Activity Self-Efficacy Scale (PASES), a 8-item 5-point Likert-scale.
  • Actual use of the intervention [ Time Frame: During the four week intervention ]
    Actual use of the intervention is tracked with log files
  • Usability of the intervention [ Time Frame: At 4 weeks ]
    Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Game Intervention to Promote the Physical Activity of Early Adolescents
Official Title  ICMJE Health Game Intervention to Promote the Physical Activity of Early Adolescents
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Physical Activity
  • Health Behavior
Intervention  ICMJE
  • Behavioral: Health game
    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.
  • Behavioral: Sport and fitness application
    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.
Study Arms  ICMJE
  • Experimental: Health game
    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.
    Intervention: Behavioral: Health game
  • Sham Comparator: Sport and fitness application
    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: Behavioral: Sport and fitness application
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Goes to school at 4th, 5th or 6th grade
  • Understands and can communicate either in Finnish
  • Has daily access to a smart phone (Android) during free time

Exclusion Criteria:

  • Physical activity impairments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279497
Other Study ID Numbers  ICMJE MoveF2017
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Anni Pakarinen, University of Turku
Study Sponsor  ICMJE University of Turku
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anni Pakarinen, MHSc University of Turku
PRS Account University of Turku
Verification Date October 2017

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