Education Against Tobacco Randomized Trial

Not Applicable

• Conditions: Adolescents; Schools; Tobacco; Prevention
• Interventions: Behavioral: Education Against Tobacco intervention

• Registration Number: NCT02697409
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-27
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-03
• Status Verified: 2016-05
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-05
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

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

Exclusion Criteria

• Not fulfilling the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Education Against Tobacco intervention	The intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools.

Primary Outcome Measures

Name	Time	Method
Smoking prevalence measured via questionnaire.	24 months post baseline	The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.

Secondary Outcome Measures

Name	Time	Method
Changes in smoking behavior	24 months post baseline	The changes in smoking behavior (smoking onset, quitting) are studied as a secondary outcome measure.
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.	24 months follow-up	Difference in attitude towards smoking between the two groups at 24 months follow-up measured via questionnaires.

Trial Locations

Locations (1)

Titus Brinker; 🇩🇪 Bünde, Germany