Smoking PreventionNCT02717910
Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents
A study testing Health game and Web page in people with Smoking Prevention, run by University of Turku at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Prevention
- What is being tested?
- Health game and Web page
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Takes part to specialized education
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Smoking Prevention
- Being tested
- Health game, Web page
- Keywords
- Games, Adolescent, Health education, Smoking, Health literacy
- Medical subject headings
- Health Education, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health gameBehavioural
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 pageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Web page |
| Group with no intervention | No intervention | The participants in this arm will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anti-smoking self-efficacy
Assessed with Anti-smoking self-efficacy scale (ASSES)
Measured: At baseline and at 2 weeks
Secondary outcomes (5)
Change in smoking outcome expectations
Assessed with Smoking Outcome Expectation scale (SOES)
Measured: At baseline and at 2 weeks
Change in attitudes towards tobacco use questionnaire scores
Assessed with a 4 point likert-scale questionnaire
Measured: At baseline and at 2 weeks
Change in tobacco use-related motives questionnaire scores
Assessed with a 4 point likert-scale questionnaire
Measured: At baseline and at 2 weeks
Actual use of the intervention
Actual use of the intervention is tracked with log files
Measured: During 2 weeks period
Self-assessed interest towards the intervention
Assessed with a 4 point likert-scale questionnaire
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Parisod, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717910
- Sponsor's protocol ID
- NTSF2016
- Status last verified
- Oct 2016
- First submitted
- 14 Mar 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02717910
- Acronym / sponsor ID
- NTSF2016
- Conditions
- Smoking Prevention
- Keywords
- Games, Adolescent, Health education, Smoking, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health game group | Experimental | Behavioral: Health gameParticipants 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. |
| Web page group | Sham comparator | Behavioral: Web pageParticipants 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. |
| Group with no intervention | No intervention | –The participants in this arm will receive no intervention. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Takes part to specialized education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health gameHealth 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. | Behavioural | Health game group |
| Web pageWeb 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. | Behavioural | Web page group |
Primary outcome
Change in anti-smoking self-efficacy
Time frame: At baseline and at 2 weeks
Assessed with Anti-smoking self-efficacy scale (ASSES)
5 secondary outcomes
Change in smoking outcome expectations
Time frame: At baseline and at 2 weeks
Change in attitudes towards tobacco use questionnaire scores
Time frame: At baseline and at 2 weeks
Change in tobacco use-related motives questionnaire scores
Time frame: At baseline and at 2 weeks
Actual use of the intervention
Time frame: During 2 weeks period
Self-assessed interest towards the intervention
Time frame: At 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health game and Web page in people with Smoking Prevention, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anti-smoking self-efficacy (time frame: At baseline and at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.