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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:
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
  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:


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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788996

Locations
Spain
Direcció General de Salut Pública, Departament de Salut, Catalunya
Barcelona, Spain, 08005
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