- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03279497
Health Game Intervention to Promote the Physical Activity of Early Adolescents
October 24, 2017 updated by: Anni Pakarinen, University of Turku
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Southwest Finland
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Turku, Southwest Finland, Finland
- Recruiting
- Primary schools (n=2)
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Contact:
- Anni Pakarinen
- Phone Number: +358451213567
- Email: anni.pakarinen@utu.fi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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.
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|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical activity behavior
Time Frame: at baseline during one week period and at 4 weeks during one week period
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Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period
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at baseline during one week period and at 4 weeks during one week period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical activity self-efficacy
Time Frame: At baseline and at 4 weeks
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Measured with Physical Activity Self-Efficacy Scale (PASES), a 8-item 5-point Likert-scale.
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At baseline and at 4 weeks
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Actual use of the intervention
Time Frame: During the four week intervention
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Actual use of the intervention is tracked with log files
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During the four week intervention
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Usability of the intervention
Time Frame: At 4 weeks
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Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale
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At 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anni Pakarinen, MHSc, University of Turku
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2017
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
September 5, 2017
First Submitted That Met QC Criteria
September 8, 2017
First Posted (Actual)
September 12, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- MoveF2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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