Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents
October 25, 2016 updated by: Heidi Parisod, University of Turku
Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents: a Feasibility Study
This feasibility study evaluates acceptability and preliminary effectiveness of a digital health game as an intervention supporting tobacco-related health literacy in 10- to 13-year-old early adolescents.
One third of the study participants will receive the health game, on third a web page with similar content and one third will act as a control group without intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
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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Three cities, Southwest Finland, Finland
- Primary schools (n=6)
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Goes to school at 4th, 5th or 6th grade
- Understands and can communicate either in Finnish, Swedish or English
- Has daily access to either a smart phone or tablet computer during free time
Exclusion Criteria:
- Takes part to specialized education
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Health game group
Participants in this arm will receive the health game intervention including both 20 minutes guided training session at school and 2 weeks free usage of the health game during free time.
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Health game intervention consists of 20 minutes guided training session with the health game at school and 2 weeks free usage of the health game via own smart phone or tablet computer during free time.
The health game includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations.
The visualized content is presented in a format of a game including tasks, rules, goals, rewards and opponents.
There are also sound effects and background music included in the game.
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Sham Comparator: Web page group
Participants in this arm will receive the web page intervention including both 20 minutes guided training session at school and 2 weeks free usage of the web page during free time.
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Web page intervention consists of 20 minutes guided training session with the web page at school and 2 weeks free usage of the web page via own smart phone or tablet computer during free time.
The web page includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations.
The visualized elements are presented with pictures and video clips.
These visualized elements do NOT contain game elements (NO activating tasks, rules, goals, rewards or opponents).
The video clips contain sound effects, but no background music.
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No Intervention: Group with no intervention
The participants in this arm will receive no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in anti-smoking self-efficacy
Time Frame: At baseline and at 2 weeks
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Assessed with Anti-smoking self-efficacy scale (ASSES)
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At baseline and at 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in smoking outcome expectations
Time Frame: At baseline and at 2 weeks
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Assessed with Smoking Outcome Expectation scale (SOES)
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At baseline and at 2 weeks
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Change in attitudes towards tobacco use questionnaire scores
Time Frame: At baseline and at 2 weeks
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Assessed with a 4 point likert-scale questionnaire
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At baseline and at 2 weeks
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Change in tobacco use-related motives questionnaire scores
Time Frame: At baseline and at 2 weeks
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Assessed with a 4 point likert-scale questionnaire
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At baseline and at 2 weeks
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Actual use of the intervention
Time Frame: During 2 weeks period
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Actual use of the intervention is tracked with log files
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During 2 weeks period
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Self-assessed interest towards the intervention
Time Frame: At 2 weeks
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Assessed with a 4 point likert-scale questionnaire
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At 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 14, 2016
First Submitted That Met QC Criteria
March 18, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- NTSF2016
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.