Education Against Tobacco Randomized Trial

June 2, 2017 updated by: Titus J. Brinker, University of Giessen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bünde, Germany, 32257
        • Titus Brinker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fulfilling the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months follow-up
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.
24 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

University Hospital Tuebingen
Universities of Giessen and Marburg Lung Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

February 27, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • EATRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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