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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01497158
Other study ID # 2007NT053
Secondary ID
Status Completed
Phase N/A
First received December 20, 2011
Last updated August 21, 2014
Start date June 2007
Est. completion date February 2012

Study information

Verified date August 2014
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Self-help brochure
Self help brochure given at baseline visit.
Biomarker feedback
Biomarker feedback from urine of adult non-smoker in the home.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). From baseline to week 12 No
Primary 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). From baseline to week 12 No
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