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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02697409
Other study ID # EATRCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 27, 2016
Last updated June 2, 2017
Start date March 2016
Est. completion date July 2019

Study information

Verified date May 2016
Source University of Giessen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20000
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Not fulfilling the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education Against Tobacco intervention


Locations

Country Name City State
Germany Titus Brinker Bünde

Sponsors (3)

Lead Sponsor Collaborator
University of Giessen Department of Psychiatry, University Hospital of Tübingen, Universities of Giessen and Marburg Lung Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking prevalence measured via questionnaire. The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires. 24 months post baseline
Secondary Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire. Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires. 24 months follow-up
Secondary Changes in smoking behavior The changes in smoking behavior (smoking onset, quitting) are studied as a secondary outcome measure. 24 months post baseline
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