NCT02717910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

March 14, 2016

Last Update Submit

October 25, 2016

Conditions

Smoking Prevention

Keywords

GamesAdolescentHealth educationSmokingHealth literacy

Outcome Measures

Primary Outcomes (1)

  • Change in anti-smoking self-efficacy

    Assessed with Anti-smoking self-efficacy scale (ASSES)

    At baseline and at 2 weeks

Secondary Outcomes (5)

  • Change in smoking outcome expectations

    At baseline and at 2 weeks

  • Change in attitudes towards tobacco use questionnaire scores

    At baseline and at 2 weeks

  • Change in tobacco use-related motives questionnaire scores

    At baseline and at 2 weeks

  • Actual use of the intervention

    During 2 weeks period

  • Self-assessed interest towards the intervention

    At 2 weeks

Study Arms (3)

Health game group

EXPERIMENTAL

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.

Behavioral: Health game

Web page group

SHAM COMPARATOR

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.

Behavioral: Web page

Group with no intervention

NO INTERVENTION

The participants in this arm will receive no intervention.

Interventions

Health gameBEHAVIORAL

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.

Health game group
Web pageBEHAVIORAL

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.

Web page group

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Takes part to specialized education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary schools (n=6)

Three Cities, Southwest Finland, Finland

Location

MeSH Terms

Conditions

Health EducationSmoking

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral candidate, MHSc

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

FI(1)