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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 : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Anni Pakarinen, University of Turku

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.

Condition or disease Intervention/treatment Phase
Physical Activity Health Behavior Behavioral: Health game Behavioral: Sport and fitness application Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Health Game Intervention to Promote the Physical Activity of Early Adolescents
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Actual use of the intervention [ Time Frame: During the four week intervention ]
    Actual use of the intervention is tracked with log files

  3. Usability of the intervention [ Time Frame: At 4 weeks ]
    Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03279497


Contacts
Contact: Anni Pakarinen, MHSc +358451213567 anni.pakarinen@utu.fi

Locations
Finland
Primary schools (n=2) Recruiting
Turku, Southwest Finland, Finland
Contact: Anni Pakarinen    +358451213567    anni.pakarinen@utu.fi   
Sponsors and Collaborators
University of Turku
Investigators
Principal Investigator: Anni Pakarinen, MHSc University of Turku

Responsible Party: Anni Pakarinen, Doctoral candidate, University of Turku
ClinicalTrials.gov Identifier: NCT03279497     History of Changes
Other Study ID Numbers: MoveF2017
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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