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Reduction of Environmental Tobacco Smoke (ETS) Exposure at Home: the BIBE Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Jordi Gol i Gurina Foundation.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Comité Nacional Prevención Tabaquismo
Catalan Society of Family Medicine
Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00788996
First received: November 9, 2008
Last updated: November 12, 2008
Last verified: November 2008
History of Changes
  Purpose

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. Smoking reduction / quitting of the mother and/or the father
  2. To determine the relationship between the level exposure to SHS and main related variables

Condition Intervention Phase
Tobacco Smoke Pollution
 Behavioral: Brief intervention based in clinical practice guide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 552
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Usual care
 Behavioral: Brief intervention based in clinical practice guide
Minimal counseling at smoking parents with babies minor 1 year-old
Other Name: Usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking parents with babies minor 1 year-old

Exclusion Criteria:

  • Parents reporting diagnosis of major psychiatric illnesses
  • Parents reporting active addictive substances consumption
  • Parents in active smoking cessation treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788996

Contacts
Contact: Ortega Guadalupe, Nurse 0034667619650 guadalupe.ortega@gencat.net

Locations
Spain
Direcció General de Salut Pública, Departament de Salut, Catalunya Not yet recruiting
Barcelona, Spain, 08005
Contact: Ortega Guadalupe, Nurse     0034667619650     guadalupe.ortega@gencat.net    
Contact: Martin Carlos, MD; PhMD     0034626981295     carlos.martin@uab.es    
Sub-Investigator: Valverde Araceli            
Sub-Investigator: Díaz Estela, Nurse            
Sub-Investigator: Ballvé José Luis, MD            
Sub-Investigator: Lozano Joan, MD            
Sub-Investigator: Morera Concepció, MD            
Sub-Investigator: Sicras Antoni, MD            
Sub-Investigator: Rofes Lourdes, MD            
Sub-Investigator: Bras Josep, MD            
Sub-Investigator: Cabezas Carmen, MD            
Sub-Investigator: Saltó Esteve, MD            
Sub-Investigator: Jané Mireia, MD            
Sub-Investigator: Martín Miguel, MD            
Sub-Investigator: Castellà Cristina, MD            
Principal Investigator: Ortega Guadalupe, Nurse            
Sub-Investigator: Lopez Grau Merce, MD            
Sub-Investigator: Roig Remon Lydia, MD            
Sub-Investigator: Altet Neus, MD            
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Comité Nacional Prevención Tabaquismo
Catalan Society of Family Medicine
Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut
Investigators
Principal Investigator: Ortega Guadalupe, Nurse Direcció General de Salut Pública. Departament de Salut. Catalunya
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Guadalupe Ortega, Catalan Society of Family Medicine
ClinicalTrials.gov Identifier: NCT00788996     History of Changes
Other Study ID Numbers: CNPT0701
Study First Received: November 9, 2008
Last Updated: November 12, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Tobacco Smoke Pollution/prevention and control
Parent-Child Relations
Environmental Tobacco Smoke (ETS)

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013