Tobacco AddictionSmokerfaceNCT02544360
A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools
A study testing Photoaging mobile app promoting poster campaign. in people with Tobacco Addiction and Smoking Related Diseases, run by University of Giessen at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Addiction, Smoking Related Diseases, Adolescent Smoking
- What is being tested?
- Photoaging mobile app promoting poster campaign.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Jul 2018
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students from Germany aged 9 to 14 years at baseline attending grades six and seven of regular German secondary schools (such as grammar, general, intermediate or comprehensive school) are eligible.
Who cannot join
- Older or younger pupils or pupils from other school types or countries or schools who previously participated in an event where the Smokerface app was presented are not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire.
Read the detailed description
This RCT will investigate a novel mean of school-based tobacco prevention: Photoaging app promoting poster campaigns. The effects are measured via questionnaire.
- Being tested
- Photoaging mobile app promoting poster campaign.
- Keywords
- photoaging mobile apps, adolescent smoking, tobacco prevention, school-based prevention, adolescent health, school health, smoking, tobacco
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoaging mobile app promoting poster campaign.Behavioural
Schools in this arm receive a photoaging mobile app promoting poster campaign revealing the effects of smoking on the users face via a self portrait (i.e. a "selfie").
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Schools in this arm receive a photoaging mobile app promoting poster campaign revealing the effects of smoking on the users face via a self portrait (i.e. a "selfie"). Receives: Behavioral: Photoaging mobile app promoting poster campaign. |
| Control | No intervention | The control group consists of schools participating in the survey but not receiving the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires.
The change in smoking prevalence between baseline and 24 months of follow-up between the two groups. A smoker is defined as someone who claims to have smoked cigarettes at least once in the past 30 days.
Measured: 24 months post intervention
Secondary outcomes (5)
Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.
Difference in attitude towards smoking between the two groups at 24 months follow-up.
Measured: 24 months post intervention
The change in never-smokers between baseline and 24 months of follow-up between the two groups measured via questionnaires.
The change in never-smokers between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Measured: 24 months post intervention
The difference in the number of quitters (=cigarette smokers at baseline but not at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
The difference in the number of quitters (=quitters are participants who are cigarette smokers at baseline but not at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Measured: 24 months post intervention
The difference in the number of starters (=starters are participants who are not cigarette smokers at baseline but at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
The difference in the number of starters (=starters are participants who are not cigarette smokers at baseline but at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Measured: 24 months post intervention
The change in smoking prevalence between baseline and 24 months of follow-up between female participants of the two groups measured via questionnaires.
Measured: 24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco AddictionStudies 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
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Goethe University, Massachusetts General Hospital, Universität Duisburg-Essen, Harvard University, University Medical Center Goettingen, University of Freiburg, University of Bonn, Technical University of Munich, University of Homburg, German Center for Lung Research, The German Heart Foundation
- Responsible party
- Principal investigator, Titus J. Brinker, University of Giessen
- Investigators
- Titus J Brinker, Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544360
- Sponsor's protocol ID
- 040890
- Acronym
- Smokerface
- Status last verified
- Jun 2016
- First submitted
- 3 Sep 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brinker TJ, Seeger W. Photoaging Mobile Apps: A Novel Opportunity for Smoking Cessation? J Med Internet Res. 2015 Jul 27;17(7):e186. doi: 10.2196/jmir.4792. No abstract available.
PubMed 26215210Brinker TJ, Holzapfel J, Baudson TG, Sies K, Jakob L, Baumert HM, Heckl M, Cirac A, Suhre JL, Mathes V, Fries FN, Spielmann H, Rigotti N, Seeger W, Herth F, Groneberg DA, Raupach T, Gall H, Bauer C, Marek P, Batra A, Harrison CH, Taha L, Owczarek A, Hofmann FJ, Thomas R, Mons U, Kreuter M. Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics. BMJ Open. 2016 Nov 7;6(11):e014288. doi: 10.1136/bmjopen-2016-014288.
PubMed 27821601
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02544360
- Acronym / sponsor ID
- Smokerface / 040890
- Keywords
- photoaging mobile apps, adolescent smoking, tobacco prevention, school-based prevention, adolescent health, school health, smoking, tobacco
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Heidelberg University, Goethe University, Massachusetts General Hospital, Universität Duisburg-Essen, Harvard University, University Medical Center Goettingen, University of Freiburg, University of Bonn, Technical University of Munich, University of Homburg, German Center for Lung Research, The German Heart Foundation
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 9 Sep 2015 (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.
The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire.
Detailed description
This RCT will investigate a novel mean of school-based tobacco prevention: Photoaging app promoting poster campaigns. The effects are measured via questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Photoaging mobile app promoting poster campaign.Schools in this arm receive a photoaging mobile app promoting poster campaign revealing the effects of smoking on the users face via a self portrait (i.e. a "selfie"). |
| Control | No intervention | –The control group consists of schools participating in the survey but not receiving the intervention. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students from Germany aged 9 to 14 years at baseline attending grades six and seven of regular German secondary schools (such as grammar, general, intermediate or comprehensive school) are eligible.
Key exclusion criteria (1 listed)
- Older or younger pupils or pupils from other school types or countries or schools who previously participated in an event where the Smokerface app was presented are not eligible.
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 |
|---|---|---|
| Photoaging mobile app promoting poster campaign.Schools in this arm receive a photoaging mobile app promoting poster campaign revealing the effects of smoking on the users face via a self portrait (i.e. a "selfie"). | Behavioural | Intervention |
Primary outcome
The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Time frame: 24 months post intervention
The change in smoking prevalence between baseline and 24 months of follow-up between the two groups. A smoker is defined as someone who claims to have smoked cigarettes at least once in the past 30 days.
5 secondary outcomes
Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.
Time frame: 24 months post intervention
The change in never-smokers between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Time frame: 24 months post intervention
The difference in the number of quitters (=cigarette smokers at baseline but not at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Time frame: 24 months post intervention
The difference in the number of starters (=starters are participants who are not cigarette smokers at baseline but at endline) between baseline and 24 months of follow-up between the two groups measured via questionnaires.
Time frame: 24 months post intervention
The change in smoking prevalence between baseline and 24 months of follow-up between female participants of the two groups measured via questionnaires.
Time frame: 24 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Background: PubMed 26215210Brinker TJ, Seeger W. Photoaging Mobile Apps: A Novel Opportunity for Smoking Cessation? J Med Internet Res. 2015 Jul 27;17(7):e186. doi: 10.2196/jmir.4792. No abstract available.
- Derived from this study: PubMed 27821601Brinker TJ, Holzapfel J, Baudson TG, Sies K, Jakob L, Baumert HM, Heckl M, Cirac A, Suhre JL, Mathes V, Fries FN, Spielmann H, Rigotti N, Seeger W, Herth F, Groneberg DA, Raupach T, Gall H, Bauer C, Marek P, Batra A, Harrison CH, Taha L, Owczarek A, Hofmann FJ, Thomas R, Mons U, Kreuter M. Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics. BMJ Open. 2016 Nov 7;6(11):e014288. doi: 10.1136/bmjopen-2016-014288.
- Description of the app we use.Link provided by the sponsor.
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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.
Titus J Brinker principal investigator
University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoaging mobile app promoting poster campaign. in people with Tobacco Addiction and Smoking Related Diseases, run by University of Giessen at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Jul 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 Germany. 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. 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?
Results are not available in the source record.
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?
The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (time frame: 24 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544360, which also lists 2 linked publications.
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 13 Jul 2016.