NCT00788996

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
552

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 9, 2008

Last Update Submit

November 12, 2008

Conditions

Tobacco Smoke Pollution

Keywords

Tobacco Smoke Pollution/prevention and controlParent-Child RelationsEnvironmental Tobacco Smoke (ETS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Usual care

Behavioral: Brief intervention based in clinical practice guide

Interventions

Brief intervention based in clinical practice guideBEHAVIORAL

Minimal counseling at smoking parents with babies minor 1 year-old

Also known as: Usual care
Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking parents with babies minor 1 year-old

You may not qualify if:

  • Parents reporting diagnosis of major psychiatric illnesses
  • Parents reporting active addictive substances consumption
  • Parents in active smoking cessation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Direcció General de Salut Pública, Departament de Salut, Catalunya

Barcelona, Barcelona, 08005, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25389300DERIVED

  • 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.

    PMID: 21171981DERIVED

Study Officials

  • Ortega Guadalupe, Nurse

    Direcció General de Salut Pública. Departament de Salut. Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ortega Guadalupe, Nurse

CONTACT

0034667619650guadalupe.ortega@gencat.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2008

First Posted

November 11, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

ES(1)