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Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause] (GESA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University Medicine Greifswald.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00647413
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

Background: Infants are at risk for tobacco-attributable diseases by being exposed to environmental tobacco smoke (ETS). International literature has shown that a home smoking ban can reduce ETS. The purpose of this study is to examine whether a brief feedback about urinary cotinine in infants and a counselling session about the consequences of ETS leads to a reduction of ETS.

All families with children up to an age of three years in the study region will be contacted by mail and asked for participation in this study. They will be randomised into an intervention and one control group. The intervention group will receive a ETS counselling session and detailed analysis of urinary cotinine (a biomarker of ETS) at their home. They will further receive written feedback approx. 2 weeks later. The control group will be visited and will answer a questionnaire and will receive brochures about ETS. They will receive a standard analysis feedback of urinary cotinine. There will be oine further assessment/ visit 12 months later. The outcome of this study is an anlysis of urinary cotinine and smoking behaviour and changes in cotinine and smoking behaviour.


Condition Intervention
Smoking
Passive Smoking
Exposure to Environmental Smoke
Behavioral: bio-chemical feedback and expert system intervention ETS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • exposure to environmental tobacco smoke [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking behaviour [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: May 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
expert system intervention on smoking behaviour + feedback of a biomarker
Behavioral: bio-chemical feedback and expert system intervention ETS

Urinary cotinien will be measured using urine collected from the infants diaper. It will be analysed and the result will be explained to the participant in a written letter approximately 2 weeks after the intervention.

The intervention will also be a counselling session about the consequences of ETS to the infant. The counselling will be guided by the principles of motivational intervieweing and an expert system letter tailored to the data assessed will be send to the participants

Other Names:
  • motivational interviewing
  • expert system intervention
  • tailored feedback

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • born in 2005, 2006 or 2007,
  • being exposed to environmental tobacco smoke at home by at least one parent, living in the study region of west pommerania

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647413

Contacts
Contact: Ulrich John, Prof. Dr. +49383486 ext 7700 ujohn@uni-greifswald.de
Contact: Jochen René Thyrian, PhD +49383486 ext 7715 thyrian@uni-greifswald.de

Locations
Germany
Institut für Epidemiologie und Sozialmedizin Not yet recruiting
Greifswald, MV, Germany, 17489
Contact: Ulrich John, Prof. PhD    +49383486 ext 7701    ujohn@uni-greifswald.de   
Contact: Jochen René Thyrian, PhD    +49383486 ext 7715    thyrian@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Study Director: Ulrich John, Prof. Dr. Institut für Epidemiologie und Sozialmedizin, University of Greifswald
Principal Investigator: Jochen René Thyrian, PhD Institut für Epidemiologie und Sozialmedizin
  More Information

No publications provided

Responsible Party: Deutsche Krebshilfe e.V., Bonn (Germany), Dr. Kohlhuber
ClinicalTrials.gov Identifier: NCT00647413     History of Changes
Other Study ID Numbers: Krebshilfe-107539, DM8-IESO02
Study First Received: March 26, 2008
Last Updated: March 28, 2008
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University Medicine Greifswald:
smoking
passive smoking
exposure to environmental smoke
home smoking ban
urinary cotinine

ClinicalTrials.gov processed this record on August 20, 2014