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

Smoking Clinical Trial

— GESA  

Official title:

Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00647413
• Other study ID #: Krebshilfe-107539
• Secondary ID: DM8-IESO02
• Status: Not yet recruiting
• Phase: N/A
• First received: March 26, 2008
• Last updated: March 28, 2008
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2008
• Source: University Medicine Greifswald
• Contact: Ulrich John, Prof. Dr.
• Phone: +49383486
• Email: ujohn[@]uni-greifswald.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Exposure to Environmental Smoke
• Passive Smoking
• Smoking

Intervention

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

Locations

Country	Name	City	State
Germany	Institut für Epidemiologie und Sozialmedizin	Greifswald	MV

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exposure to environmental tobacco smoke		6 months	No
Secondary	smoking behaviour		6 months	No