Education Against Tobacco Randomized Trial in Bosnia and Herzegovina

Tobacco Clinical Trial

Official title:

Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02731547
• Other study ID #: RCTBosnia
• Status: Not yet recruiting
• Phase: N/A
• First received: April 3, 2016
• Last updated: April 12, 2016
• Start date: May 2016

Study information

• Verified date: April 2016
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• 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 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Not fulfilling inclusion criteria.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schools
• Tobacco
• Tobacco Prevention

Intervention

Behavioral:
• Education Against Tobacco School-Based Intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	University of Dhaka, Shaheed Monsur Ali Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking prevalence measured via questionnaire.		12 months follow-up	No
Secondary	Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline		Baseline and 12 months	No
Secondary	Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline		Baseline and 12 months	No
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 12 months follow-up measured via questionnaires.	Baseline and 12 months	No