P60 Program Project Grant-Outreach for Smoke-Free Homes

Not Applicable

Completed

• Conditions: Smoking Cessation; Tobacco Cessation
• Interventions: Behavioral: Counseling; Behavioral: Brochure

• Registration Number: NCT01574560
• Lead Sponsor: University of Minnesota

Brief Summary

Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.

Detailed Description

This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.

Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group - Counseling	Counseling	This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking.
Control Group - Health Education	Brochure	This group is provided with information regarding secondhand smoke and creating a healthy home environment.

Primary Outcome Measures

Name	Time	Method
Change in Home Secondhand Smoke levels	From Baseline to Week 26 Follow-Up	Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.

Secondary Outcome Measures

Name	Time	Method
Comparison of Child Cotinine Levels in Urine	From Baseline to Week 26 Follow-Up	Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Child (non-smoker) cotinine will be used as an objective measure of secondhand smoke exposure at baseline and again at end of study (week 26).
Comparison of Questionnaire Results	Baseline, Week 16 and Week 26	Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States