Back to resultsPromoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults
Primary Purpose
Smoking Cessation, Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-help brochure
Biomarker feedback
Sponsored by
About this trial
This is an interventional prevention trial for Smoking Cessation focused on measuring tobacco cessation
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Group
Active Group
Arm Description
Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.
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.
Outcomes
Primary Outcome Measures
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01497158
First Posted
December 20, 2011
Last Updated
August 21, 2014
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01497158
Brief Title
Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults
Official Title
Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Tobacco Use Disorder
Keywords
tobacco cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.
Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Self-help brochure
Intervention Description
Self help brochure given at baseline visit.
Intervention Type
Other
Intervention Name(s)
Biomarker feedback
Intervention Description
Biomarker feedback from urine of adult non-smoker in the home.
Primary Outcome Measure Information:
Title
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling
Description
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).
Time Frame
From baseline to week 12
Title
Comparison of Self-Reported Home Smoking Restrictions - Control Group
Description
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).
Time Frame
From baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Thomas, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455'
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults
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