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Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01497158
First received: December 20, 2011
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.


Condition Intervention
Smoking Cessation
Tobacco Use Disorder
 Other: Self-help brochure
Other: Biomarker feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Comparison of Self-Reported Home Smoking Restrictions - Active Counseling [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).

  • Comparison of Self-Reported Home Smoking Restrictions - Control Group [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).


Enrollment: 122
Study Start Date: June 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.
 Other: Self-help brochure
Self help brochure given at baseline visit.
Active Comparator: Active Group
Participants who received self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home and biomarker feedback from the urine of cohabitating adult non-smoker in the home.
 Other: Self-help brochure
Self help brochure given at baseline visit.
Other: Biomarker feedback
Biomarker feedback from urine of adult non-smoker in the home.

Detailed Description:

This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • Cohabitating Non-Smoker (control) and smoker (active)
  • Smoker must test > 6ppm on carbon dioxide (CO) test and non-smoker < 6ppm
  • General good health
  • Written informed consent
  • Live within Twin Cities 7 county metropolitan area (Minnesota)
  • Plan to live in same home for 6 months and be willing for researchers to come to their home

Exclusion Criteria:

  • Individuals that live in a treatment facility or shelter
  • Individuals endorsing current domestic violence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497158

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455`
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Janet Thomas, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01497158     History of Changes
Other Study ID Numbers: 2007NT053
Study First Received: December 20, 2011
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
tobacco cessation

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013