Clinical trial NCT00788996: Reduction of Environmental Tobacco Smoke (ETS) Exposure at Home: the BIBE Study
Official title: Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tobacco Smoke Pollution
Keywords: Tobacco Smoke Pollution/prevention and control
Parent-Child Relations
Environmental Tobacco Smoke (ETS)
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Comité Nacional Prevención Tabaquismo
name: Catalan Society of Family Medicine
name: Unitat Suport Recerca Àmbit Atenció Primària Barcelona. Institut Català Salut
First posted: 2008-11-11
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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


Eligibility 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

Primary outcomes:
measure: The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis.
timeFrame: 6 months at the beginning of intervention
Secondary outcomes:
measure: 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
timeFrame: 6 months at the beginning of intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Direcció General de Salut Pública, Departament de Salut, Catalunya
Study officials:
affiliation: Direcció General de Salut Pública. Departament de Salut. Catalunya
name: Ortega Guadalupe, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortega Cuelva G, Cabezas Pena C, Almeda Ortega J, Saez Zafra M, Ballve Moreno JL, Pascual Esteban JA, Castella Cuesta C, Martin-Cantera C, Salto Cerezuela E, Casademont Pou RM, Diaz Alvarez E, Lozano Fernandez J, Morera Jordan C, Valverde Trillo A, Perez-Ortuno R, Rofes Ponce L, Jane Checa M; BIBE study group. Effectiveness of a brief primary care intervention to reduce passive smoking in babies: a cluster randomised clinical trial. J Epidemiol Community Health. 2015 Mar;69(3):249-60. doi: 10.1136/jech-2014-204708. Epub 2014 Nov 11.
citation: Ortega G, Castella C, Martin-Cantera C, Ballve JL, Diaz E, Saez M, Lozano J, Rofes L, Morera C, Barcelo A, Cabezas C, Pascual JA, Perez-Ortuno R, Salto E, Valverde A, Jane M; BIBE Study Group. Passive smoking in babies: the BIBE study (Brief Intervention in babies. Effectiveness). BMC Public Health. 2010 Dec 20;10:772. doi: 10.1186/1471-2458-10-772.