SmokingNCT03178227
Smokerface Mirroring in Brazil RCT
A study testing Photoaging Mirroring Intervention in people with Smoking, run by University of Giessen at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Photoaging Mirroring Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Visiting a Brazilian secondary school
Who cannot join
- Not visiting a Brazilian secondary school
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site
University of Itauna
Itaúna
Breno Bernardes, MD, brenoneps@gmail.com
Germany1 site
Titus Brinker
Bünde, 32257
Titus Brinker, +4917647753318, titus.brinker@gmail.com
About this study
Official title: Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Photoaging Mirroring Intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoaging Mirroring InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention is a school-based intervention involving photoaging of the students selfies which takes 45 minutes total. Receives: Behavioral: Photoaging Mirroring Intervention |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
The difference of prevalences after one month
The secondary outcome is the difference of the smoking prevalence from baseline to one month follow-up between the two groups.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Feb 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Titus J. Brinker, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178227
- Sponsor's protocol ID
- SmokerfaceMirrorBrazil
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29229659
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol
- ClinicalTrials.gov ID
- NCT03178227
- Acronym / sponsor ID
- SmokerfaceMirrorBrazil
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Photoaging Mirroring InterventionThe intervention is a school-based intervention involving photoaging of the students selfies which takes 45 minutes total. |
| Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Visiting a Brazilian secondary school
Key exclusion criteria (1 listed)
- Not visiting a Brazilian secondary school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoaging Mirroring InterventionMedical 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. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
The difference of prevalences after one month
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Derived from this study: PubMed 29229659Faria 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoaging Mirroring Intervention in people with Smoking, run by University of Giessen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Titus J Brinker (15175084347, titus.brinker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of prevalences after six months (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03178227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.