Education Against Tobacco Randomized Trial in Brazil

Tobacco Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02725021
• Other study ID #: EATBrazil
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2016
• Last updated: June 2, 2017
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• 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 school. The primary endpoint is the change in smoking prevalence between the two groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• Visiting grades 7-11 of a regular public secondary school in Brazil.

Exclusion Criteria:

• Not fulfilling inclusion criteria.

Related Conditions & MeSH terms

• Tobacco Prevention

Intervention

Behavioral:
• Education Against Tobacco school-based intervention by medical students

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking prevalence measured via questionnaire.		12 months follow-up
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
Secondary	Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline		Baseline and 12 months
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.