Smokerface Mirroring in Brazil RCT


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Verified June 2017 by Titus J. Brinker, Universität Duisburg-Essen

Sponsor:

Information provided by (Responsible Party):

Titus J. Brinker, Universität Duisburg-Essen

ClinicalTrials.gov Identifier:

NCT03178227

First received: June 2, 2017

Last updated: June 2, 2017

Last verified: June 2017

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.

Smoking Behavioral: Photoaging Mirroring Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil – Study Protocol

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 1000
Anticipated Study Start Date: February 1, 2018
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

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.

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

Inclusion Criteria:

Visiting a Brazilian secondary school

Exclusion Criteria:

Not visiting a Brazilian secondary school

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03178227

University of Itauna
Itauna, Brazil
Contact: Breno Bernardes, MD       brenoneps@gmail.com   
Titus Brinker
Bünde, Germany, 32257
Contact: Titus Brinker    +4917647753318    titus.brinker@gmail.com   

University of Giessen

Responsible Party: Titus J. Brinker, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03178227     History of Changes
Other Study ID Numbers: SmokerfaceMirrorBrazil
Study First Received: June 2, 2017
Last Updated: June 2, 2017

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

ClinicalTrials.gov processed this record on June 06, 2017