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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02544360
Other study ID # 040890
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 3, 2015
Last updated July 11, 2016
Start date September 2015
Est. completion date July 2018

Study information

Verified date June 2016
Source University of Giessen
Contact n/a
Is FDA regulated No
Health authority Germany: The Coordinating Centre for Clinical Trials (KKS), Marburg, Germany
Study type Interventional

Clinical 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.


Description:

This RCT will investigate a novel mean of school-based tobacco prevention: Photoaging app promoting poster campaigns. The effects are measured via questionnaire.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12000
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 17 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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").

Locations

Country Name City State
Germany University of Gießen Giessen Hessen

Sponsors (13)

Lead Sponsor Collaborator
University of Giessen German Center for Lung Research, Goethe University, Harvard University, Heidelberg University, Massachusetts General Hospital, Technische Universität München, The German Heart Foundation, Universität Duisburg-Essen, University Medical Center Goettingen, University of Bonn, University of Freiburg, University of Homburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 months post intervention No
Secondary 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. 24 months post intervention No
Secondary 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. 24 months post intervention No
Secondary 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. 24 months post intervention No
Secondary 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. 24 months post intervention No
Secondary The change in smoking prevalence between baseline and 24 months of follow-up between female participants of the two groups measured via questionnaires. 24 months post intervention No
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Completed NCT01785147 - Efficacy and Safety of BP1.4979 in Smoking Cessation Phase 2
Recruiting NCT01038414 - Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence Phase 4
Completed NCT02000921 - Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors N/A

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