Tobacco Smoke PollutionPhase 2BIBENCT00788996
Reduction of Environmental Tobacco Smoke (ETS) Exposure at Home: the BIBE Study
A Phase 2 study testing Brief intervention based in clinical practice guide in people with Tobacco Smoke Pollution, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Main objective: to determine the effectiveness of a brief opportunist educational performance directed to the parents who smoke -- inside the context of programmed visits of paediatrics in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS) Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoke Pollution
- What is being tested?
- Brief intervention based in clinical practice guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking parents with babies minor 1 year-old
Who cannot join
- Parents reporting diagnosis of major psychiatric illnesses
- Parents reporting active addictive substances consumption
- Parents in active smoking cessation treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Direcció General de Salut Pública, Departament de Salut, Catalunya
Barcelona, Barcelona, 08005
Ortega Guadalupe, Nurse, 0034667619650, guadalupe.ortega@gencat.net
Martin Carlos, MD; PhMD, 0034626981295, carlos.martin@uab.es
About this study
Official title: Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE
Main objective: to determine the effectiveness of a brief opportunist educational performance directed to the parents who smoke -- inside the context of programmed visits of paediatrics in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS)
Secondary objectives:
- Smoking reduction / quitting of the mother and/or the father
- To determine the relationship between the level exposure to SHS and main related variables
- Conditions
- Tobacco Smoke Pollution
- Being tested
- Brief intervention based in clinical practice guide
- Keywords
- Tobacco Smoke Pollution/prevention and control, Parent-Child Relations, Environmental Tobacco Smoke (ETS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention based in clinical practice guideBehavioural
Also called Usual care
Minimal counseling at smoking parents with babies minor 1 year-old
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Usual care Receives: Behavioral: Brief intervention based in clinical practice guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis.
Measured: 6 months at the beginning of intervention
Secondary outcomes (1)
Parental smoking quitting or reduction by questionnaire and CO monitoring to whom self declared abstinent. Health related variables of babies and parents by follow-up questionnaire
Measured: 6 months at the beginning of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Smoke PollutionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Comité Nacional Prevención Tabaquismo, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut
- Investigators
- Ortega Guadalupe, Nurse, Principal investigator, Direcció General de Salut Pública. Departament de Salut. Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788996
- Sponsor's protocol ID
- CNPT0701
- Acronym
- BIBE
- Status last verified
- Nov 2008
- First submitted
- 9 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ortega Cuelva G, Cabezas Pena C, Almeda Ortega J, Saez Zafra M, Ballve Moreno JL, Pascual Esteban JA, Castella Cuesta C, Martin-Cantera C, Salto Cerezuela E, Casademont Pou RM, Diaz Alvarez E, Lozano Fernandez J, Morera Jordan C, Valverde Trillo A, Perez-Ortuno R, Rofes Ponce L, Jane Checa M; BIBE study group. Effectiveness of a brief primary care intervention to reduce passive smoking in babies: a cluster randomised clinical trial. J Epidemiol Community Health. 2015 Mar;69(3):249-60. doi: 10.1136/jech-2014-204708. Epub 2014 Nov 11.
PubMed 25389300Ortega G, Castella C, Martin-Cantera C, Ballve JL, Diaz E, Saez M, Lozano J, Rofes L, Morera C, Barcelo A, Cabezas C, Pascual JA, Perez-Ortuno R, Salto E, Valverde A, Jane M; BIBE Study Group. Passive smoking in babies: the BIBE study (Brief Intervention in babies. Effectiveness). BMC Public Health. 2010 Dec 20;10:772. doi: 10.1186/1471-2458-10-772.
PubMed 21171981
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE
- ClinicalTrials.gov ID
- NCT00788996
- Acronym / sponsor ID
- BIBE / CNPT0701
- Conditions
- Tobacco Smoke Pollution
- Keywords
- Tobacco Smoke Pollution/prevention and control, Parent-Child Relations, Environmental Tobacco Smoke (ETS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Comité Nacional Prevención Tabaquismo, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 11 Nov 2008 (estimated)
- 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.
Main objective: to determine the effectiveness of a brief opportunist educational performance directed to the parents who smoke -- inside the context of programmed visits of paediatrics in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS)
Secondary objectives:
- Smoking reduction / quitting of the mother and/or the father
- To determine the relationship between the level exposure to SHS and main related variables
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Brief intervention based in clinical practice guideUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoking parents with babies minor 1 year-old
Key exclusion criteria (3 listed)
- Parents reporting diagnosis of major psychiatric illnesses
- Parents reporting active addictive substances consumption
- Parents in active smoking cessation treatment
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 |
|---|---|---|
| Brief intervention based in clinical practice guideAlso: Usual careMinimal counseling at smoking parents with babies minor 1 year-old | Behavioural | Lifestyle counseling |
Primary outcome
The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis.
Time frame: 6 months at the beginning of intervention
1 secondary outcome
Parental smoking quitting or reduction by questionnaire and CO monitoring to whom self declared abstinent. Health related variables of babies and parents by follow-up questionnaire
Time frame: 6 months at the beginning of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
- Derived from this study: PubMed 25389300Ortega Cuelva G, Cabezas Pena C, Almeda Ortega J, Saez Zafra M, Ballve Moreno JL, Pascual Esteban JA, Castella Cuesta C, Martin-Cantera C, Salto Cerezuela E, Casademont Pou RM, Diaz Alvarez E, Lozano Fernandez J, Morera Jordan C, Valverde Trillo A, Perez-Ortuno R, Rofes Ponce L, Jane Checa M; BIBE study group. Effectiveness of a brief primary care intervention to reduce passive smoking in babies: a cluster randomised clinical trial. J Epidemiol Community Health. 2015 Mar;69(3):249-60. doi: 10.1136/jech-2014-204708. Epub 2014 Nov 11.
- Derived from this study: PubMed 21171981Ortega G, Castella C, Martin-Cantera C, Ballve JL, Diaz E, Saez M, Lozano J, Rofes L, Morera C, Barcelo A, Cabezas C, Pascual JA, Perez-Ortuno R, Salto E, Valverde A, Jane M; BIBE Study Group. Passive smoking in babies: the BIBE study (Brief Intervention in babies. Effectiveness). BMC Public Health. 2010 Dec 20;10:772. doi: 10.1186/1471-2458-10-772.
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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.
Ortega Guadalupe, Nurse principal investigator
Direcció General de Salut Pública. Departament de Salut. Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief intervention based in clinical practice guide in people with Tobacco Smoke Pollution, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 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 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ortega Guadalupe, Nurse (0034667619650, guadalupe.ortega@gencat.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. (time frame: 6 months at the beginning of intervention). 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 NCT00788996, which also lists 2 linked publications.
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 13 Nov 2008.