NCT02731547

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 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

April 3, 2016

Last Update Submit

April 12, 2016

Conditions

Tobacco PreventionTobaccoSchools

Outcome Measures

Primary Outcomes (1)

  • Smoking prevalence measured via questionnaire.

    12 months follow-up

Secondary Outcomes (3)

  • 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

  • Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline

    Baseline and 12 months

  • Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.

    Baseline and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

Education Against Tobacco School-Based InterventionBEHAVIORAL
Intervention group

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cand. med. Titus J. Brinker

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 7, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Last Updated

April 13, 2016

Record last verified: 2016-04