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

November 12, 2008 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

552

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months at the beginning of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months at the beginning of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Catalan Society of Family Medicine
Comité Nacional Prevención Tabaquismo
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

November 9, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CNPT0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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