- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725021
Education Against Tobacco Randomized Trial in Brazil
June 2, 2017 updated by: Titus J. Brinker, University of Giessen
Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Brazil - 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 school.
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
5 years to 25 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Visiting grades 7-11 of a regular public secondary school in Brazil.
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
- Masking: NONE
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.
|
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 |
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: Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
|
Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Xavier 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.
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
October 1, 2016
Primary Completion (ANTICIPATED)
February 1, 2018
Study Completion (ANTICIPATED)
April 1, 2018
Study Registration Dates
First Submitted
March 13, 2016
First Submitted That Met QC Criteria
March 30, 2016
First Posted (ESTIMATE)
March 31, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EATBrazil
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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