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
  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:


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
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: 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 July 24, 2014