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

NCT00647413 | Unknown

• 2 other identifiers: Krebshilfe-107539DM8-IESO02
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Passive Smoking; Exposure to Environmental Smoke

Keywords

smoking; passive smoking; exposure to environmental smoke; home smoking ban; urinary cotinine

Outcome Measures

Primary Outcomes (1)

• exposure to environmental tobacco smoke

  6 months

Secondary Outcomes (1)

• smoking behaviour

  6 months

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

expert system intervention on smoking behaviour + feedback of a biomarker

Behavioral: bio-chemical feedback and expert system intervention ETS

Interventions

bio-chemical feedback and expert system intervention ETS BEHAVIORAL

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

Also known as: motivational interviewing, expert system intervention, tailored feedback

2

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (1)

Institut für Epidemiologie und Sozialmedizin

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

Related Publications (1)

• Ulbricht S, Gross S, Meyer C, Hannover W, Nauck M, John U. Reducing tobacco smoke exposure in children aged below 4 years - a randomized controlled trial. Prev Med. 2014 Dec;69:208-13. doi: 10.1016/j.ypmed.2014.10.016. Epub 2014 Oct 18.

  PMID: 25456808 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ulrich John, Prof. Dr.

  Institut für Epidemiologie und Sozialmedizin, University of Greifswald

  STUDY DIRECTOR

• Jochen René Thyrian, PhD

  Institut für Epidemiologie und Sozialmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich John, Prof. Dr.

CONTACT

+49383486; ujohn@uni-greifswald.de

Jochen René Thyrian, PhD

CONTACT

+49383486; thyrian@uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 31, 2008

Record last verified: 2008-03

Locations

DE (1)