NCT03178227

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

June 2, 2017

Last Update Submit

June 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The difference of prevalences after six months

    The primary outcome is the difference of the smoking prevalence from baseline to six months follow-up between the two groups.

    six months

Secondary Outcomes (1)

  • The difference of prevalences after one month

    1 month

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is a school-based intervention involving photoaging of the students selfies which takes 45 minutes total.

Behavioral: Photoaging Mirroring Intervention

Control

NO INTERVENTION

No intervention.

Interventions

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.

Intervention

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Visiting a Brazilian secondary school

You may not qualify if:

  • Not visiting a Brazilian secondary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Itauna

Itaúna, Brazil

Location

Titus Brinker

Bünde, 32257, Germany

Location

Related Publications (1)

  • Faria BL, Brieske CM, Cosgarea I, Omlor AJ, Fries FN, de Faria COM, Lino HA, Oliveira ACC, Lisboa OC, Klode J, Schadendorf D, Bernardes-Souza B, Brinker TJ. A smoking prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised trial. BMJ Open. 2017 Dec 10;7(12):e018589. doi: 10.1136/bmjopen-2017-018589.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

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
Titus J. Brinker

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

February 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations