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A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools (Smokerface)

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ClinicalTrials.gov Identifier: NCT02544360
Recruitment Status : Unknown
Verified June 2016 by Titus J. Brinker, University of Giessen.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : July 13, 2016
Sponsor:
Collaborators:
Heidelberg University
Goethe University
Massachusetts General Hospital
Universität Duisburg-Essen
Harvard University
University Medical Center Goettingen
University of Freiburg
University of Bonn
Technische Universität München
University of Homburg
German Center for Lung Research
The German Heart Foundation
Information provided by (Responsible Party):
Titus J. Brinker, University of Giessen

Tracking Information
First Submitted Date  ICMJE September 3, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools
Official Title  ICMJE Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Tobacco Addiction
  • Smoking Related Diseases
  • Adolescent Smoking
Intervention  ICMJE 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").
Study Arms  ICMJE
  • 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").
    Intervention: Behavioral: Photoaging mobile app promoting poster campaign.
  • No Intervention: Control
    The control group consists of schools participating in the survey but not receiving the intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)
12000
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2015)
20000
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02544360
Other Study ID Numbers  ICMJE 040890
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Titus J. Brinker, University of Giessen
Study Sponsor  ICMJE University of Giessen
Collaborators  ICMJE
  • Heidelberg University
  • Goethe University
  • Massachusetts General Hospital
  • Universität Duisburg-Essen
  • Harvard University
  • University Medical Center Goettingen
  • University of Freiburg
  • University of Bonn
  • Technische Universität München
  • University of Homburg
  • German Center for Lung Research
  • The German Heart Foundation
Investigators  ICMJE
Principal Investigator: Titus J Brinker University of Giessen
PRS Account University of Giessen
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP