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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788996
First Posted: November 11, 2008
Last Update Posted: November 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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