Education Against Tobacco Randomized Trial in Bosnia and Herzegovina

April 12, 2016 updated by: Titus J. Brinker, University of Giessen

Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - 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 7-11th grade of secondary schools in Bosnia and Herzegovina. 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)

1500

Phase

  • Not Applicable

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

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina.

Exclusion Criteria:

Not fulfilling 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 a school-based module taking about two hours delivered by medical students in the schools.
Behavioral: Education Against Tobacco School-Based Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Smoking prevalence measured via questionnaire.
Time Frame: 12 months follow-up
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline
Time Frame: Baseline and 12 months
Baseline and 12 months
Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline
Time Frame: Baseline and 12 months
Baseline and 12 months
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
Time Frame: Baseline and 12 months
Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
Baseline and 12 months

Collaborators and Investigators

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

Sponsor

University of Giessen

Collaborators

University of Dhaka

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

May 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 3, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RCTBosnia

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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