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Smokerface Mirroring in Brazil RCT

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ClinicalTrials.gov Identifier: NCT03178227
Recruitment Status : Not yet recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Titus J. Brinker, Universität Duisburg-Essen

Brief Summary:
Before February 2018 the baseline survey is conducted in about 60 class in Brazilian secondary schools. These classes are randomized to control and intervention group in a 1/1 manner. A few weeks thereafter medical students from the local medical school visit the schools and perform a smoking prevention intervention called "photoaging mirroring intervention" which takes about 45 minutes. One month and six months after the intervention the intervention group receives another anonymous questionnaire monitoring smoking status. The primary endpoint is the difference in the chance of smoking prevalence between the two groups.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Photoaging Mirroring Intervention Not Applicable

Detailed Description:
Before February 2018 the baseline survey is conducted in about 60 class in Brazilian secondary schools. These classes are randomized to control and intervention group in a 1/1 manner. A few weeks thereafter medical students from the local medical school visit the schools and perform a smoking prevention intervention called "photoaging mirroring intervention" which takes about 45 minutes. One month and six months after the intervention the intervention group receives another anonymous questionnaire monitoring smoking status. The primary endpoint is the difference in the chance of smoking prevalence between the two groups.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Intervention
The intervention is a school-based intervention involving photoaging of the students selfies which takes 45 minutes total.
Behavioral: Photoaging Mirroring Intervention
Medical students perform "mirroring" with the pupils in the schools where they shoot selfies with tablets and photoage them to future non-smokers vs. future smokers.

No Intervention: Control
No intervention.



Primary Outcome Measures :
  1. The difference of prevalences after six months [ Time Frame: six months ]
    The primary outcome is the difference of the smoking prevalence from baseline to six months follow-up between the two groups.


Secondary Outcome Measures :
  1. The difference of prevalences after one month [ Time Frame: 1 month ]
    The secondary outcome is the difference of the smoking prevalence from baseline to one month follow-up between the two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Visiting a Brazilian secondary school

Exclusion Criteria:

Not visiting a Brazilian secondary school


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178227


Contacts
Contact: Titus J Brinker 15175084347 titus.brinker@gmail.com

Locations
Brazil
University of Itauna Recruiting
Itauna, Brazil
Contact: Breno Bernardes, MD       brenoneps@gmail.com   
Germany
Titus Brinker Not yet recruiting
Bünde, Germany, 32257
Contact: Titus Brinker    +4917647753318    titus.brinker@gmail.com   
Sponsors and Collaborators
University of Giessen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Titus J. Brinker, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03178227     History of Changes
Other Study ID Numbers: SmokerfaceMirrorBrazil
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No