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

Sponsor

Jordi Gol i Gurina Foundation (Other)

Overall Status

Unknown status

CT.gov ID

NCT00788996

Collaborator

Comité Nacional Prevención Tabaquismo (Other), Catalan Society of Family Medicine (Other), Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut (Other)

552

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

552 participants

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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2010

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Usual care

Arm

Intervention/Treatment

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 Names:

Usual care

Outcome Measures

Primary Outcome Measures

The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. [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 [6 months at the beginning of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00788996

Other Study ID Numbers:

CNPT0701

First Posted:

Nov 11, 2008

Last Update Posted:

Nov 13, 2008

Last Verified:

Nov 1, 2008

Keywords provided by , ,

Tobacco Smoke Pollution/prevention and control

Parent-Child Relations

Environmental Tobacco Smoke (ETS)

Study Results

No Results Posted as of Nov 13, 2008