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Education Against Tobacco Randomized Trial

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ClinicalTrials.gov Identifier: NCT02697409
Recruitment Status : Unknown
Verified May 2016 by Titus J. Brinker, University of Giessen.
Recruitment status was:  Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
University Hospital Tuebingen
Universities of Giessen and Marburg Lung Center
Information provided by (Responsible Party):
Titus J. Brinker, University of Giessen

Tracking Information
First Submitted Date  ICMJE February 27, 2016
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date June 5, 2017
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
Smoking prevalence measured via questionnaire. [ Time Frame: 24 months post baseline ]
The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
Smoking prevalence measured via questionnaires [ Time Frame: 24 months post baseline ]
The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.
Change History Complete list of historical versions of study NCT02697409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2016)
  • Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire. [ Time Frame: 24 months follow-up ]
    Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.
  • Changes in smoking behavior [ Time Frame: 24 months post baseline ]
    The changes in smoking behavior (smoking onset, quitting) are studied as a secondary outcome measure.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaires [ Time Frame: 24 months follow-up ]
Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Education Against Tobacco Randomized Trial
Official Title  ICMJE Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco Randomized Trial
Brief Summary A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.
Detailed Description Not Provided
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
  • Prevention
  • Adolescents
  • Schools
Intervention  ICMJE Behavioral: Education Against Tobacco intervention
Study Arms  ICMJE
  • Experimental: Intervention group
    The intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools.
    Intervention: Behavioral: Education Against Tobacco intervention
  • No Intervention: Control group
Publications * Not Provided

*   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)
20000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pupils of 7th grade of regular secondary schools in Germany

Exclusion Criteria:

  • Not fulfilling the inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
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 NCT02697409
Other Study ID Numbers  ICMJE EATRCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Titus J. Brinker, University of Giessen
Study Sponsor  ICMJE University of Giessen
Collaborators  ICMJE
  • University Hospital Tuebingen
  • Universities of Giessen and Marburg Lung Center
Investigators  ICMJE Not Provided
PRS Account University of Giessen
Verification Date May 2016

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