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

Tobacco Smoke Pollution Clinical Trial

— BIBE  

Official title:

Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00788996
• Other study ID #: CNPT0701
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 9, 2008
• Last updated: November 12, 2008
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2008
• Source: Jordi Gol i Gurina Foundation
• Contact: Ortega Guadalupe, Nurse
• Phone: 0034667619650
• Email: guadalupe.ortega[@]gencat.net
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 552
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Smoke Pollution

Intervention

Behavioral:
• Brief intervention based in clinical practice guide
Minimal counseling at smoking parents with babies minor 1 year-old

Locations

Country	Name	City	State
Spain	Direcció General de Salut Pública, Departament de Salut, Catalunya	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Society of Family Medicine, Comité Nacional Prevención Tabaquismo, Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis.		6 months at the beginning of intervention	No
Secondary	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		6 months at the beginning of intervention	No