Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents

Smoking Prevention Clinical Trial

Official title:

Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717910
• Other study ID #: NTSF2016
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: October 25, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Prevention

Intervention

Behavioral:
• Health game
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.
• Web page
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.

Locations

Country	Name	City	State
Finland	Primary schools (n=6)	Three cities	Southwest Finland

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anti-smoking self-efficacy	Assessed with Anti-smoking self-efficacy scale (ASSES)	At baseline and at 2 weeks	No
Secondary	Change in smoking outcome expectations	Assessed with Smoking Outcome Expectation scale (SOES)	At baseline and at 2 weeks	No
Secondary	Change in attitudes towards tobacco use questionnaire scores	Assessed with a 4 point likert-scale questionnaire	At baseline and at 2 weeks	No
Secondary	Change in tobacco use-related motives questionnaire scores	Assessed with a 4 point likert-scale questionnaire	At baseline and at 2 weeks	No
Secondary	Actual use of the intervention	Actual use of the intervention is tracked with log files	During 2 weeks period	No
Secondary	Self-assessed interest towards the intervention	Assessed with a 4 point likert-scale questionnaire	At 2 weeks	No