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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

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.

Condition or disease Intervention/treatment Phase
Tobacco Prevention Adolescents Schools Behavioral: Education Against Tobacco intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco Randomized Trial
Study Start Date : March 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Intervention group
The intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools.
Behavioral: Education Against Tobacco intervention
No Intervention: Control group



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fulfilling the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697409


Locations
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Germany
Titus Brinker
Bünde, Germany, 32257
Sponsors and Collaborators
University of Giessen
University Hospital Tuebingen
Universities of Giessen and Marburg Lung Center

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Responsible Party: Titus J. Brinker, cand. med., University of Giessen
ClinicalTrials.gov Identifier: NCT02697409     History of Changes
Other Study ID Numbers: EATRCT
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided