- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544360
A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools (Smokerface)
July 11, 2016 updated by: Titus J. Brinker, University of Giessen
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
12000
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
-
-
Hessen
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Giessen, Hessen, Germany, 35392
- University of Gießen
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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
9 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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").
|
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").
|
No Intervention: Control
The control group consists of schools participating in the survey but not receiving the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.
Time Frame: 24 months post intervention
|
Difference in attitude towards smoking between the two groups at 24 months follow-up.
|
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 change in never-smokers between baseline and 24 months of follow-up between the two groups measured via questionnaires.
|
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 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.
|
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 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.
|
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
|
24 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Titus J Brinker, University of Gießen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Brinker 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.
Helpful Links
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
September 1, 2015
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
September 3, 2015
First Submitted That Met QC Criteria
September 8, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 11, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040890
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.
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