Education Against Tobacco Randomized Trial in Brazil
Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Brazil - Randomized Trial
1 other identifier
interventional
1,500
0 countries
N/A
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 school. The primary endpoint is the change in smoking prevalence between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJune 5, 2017
April 1, 2016
1.3 years
March 13, 2016
June 2, 2017
Conditions
Keywords
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.
Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
Study Arms (2)
Intervention group
EXPERIMENTALThe intervention group receives a school-based module taking about two hours delivered by medical students in the schools.
Control group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Visiting grades 7-11 of a regular public secondary school in Brazil.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Lisboa OC, Bernardes-Souza B, Xavier LEF, Almeida MR, Correa PCRP, Brinker TJ. A Smoking Prevention Program Delivered by Medical Students to Secondary Schools in Brazil Called "Education Against Tobacco": Randomized Controlled Trial. J Med Internet Res. 2019 Feb 21;21(2):e12854. doi: 10.2196/12854.
PMID: 30789347DERIVEDXavier LE, Bernardes-Souza B, Lisboa OC, Seeger W, Groneberg DA, Tran TA, Fries FN, Correa PC, Brinker TJ. A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Brazil: Study Protocol for a Randomized Trial. JMIR Res Protoc. 2017 Jan 30;6(1):e16. doi: 10.2196/resprot.7134.
PMID: 28137703DERIVED
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
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2016
First Posted
March 31, 2016
Study Start
October 1, 2016
Primary Completion
February 1, 2018
Study Completion
April 1, 2018
Last Updated
June 5, 2017
Record last verified: 2016-04