Education Against Tobacco Randomized Trial

Prevention Clinical Trial

Official title:

Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02697409
• Other study ID #: EATRCT
• 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
• 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

Related Conditions & MeSH terms

• Adolescents
• Prevention
• Schools
• Tobacco

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