P60 Program Project Grant-Outreach for Smoke-Free Homes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Community Outreach and Biomarker Feedback for Smoke-Free Homes

Conditions
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Smoking Cessation, Tobacco Cessation

Intervention / Treatment
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* Behavioral: Brochure
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (adult): Age 18 years or older Female Smoked ≥ 1 cigarettes per day for at least the past 6 months Smoked on 20 days or more in the last month Smoking status confirmed via cotinine verification strips Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver Will agree to provide a urine sample at study enrollment Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample) Has a home address Has a functioning home phone or cell phone Provides written informed consent Inclusion criteria (child): < or = 10 years of age Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child Lives in the primary home with the adult study participant at least 5 days a week Exclusion criteria (adult): Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation Planning to move outside of Minnesota within the next 3 months Have complete home smoking restrictions currently in place verified by the nicotine dosimeter Currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group - Health Education<br>This group is provided with information regarding secondhand smoke and creating a healthy home environment. | Behavioral: Brochure<br>* Information regarding secondhand smoke and creating a healthy home environment.<br>|
| Active Comparator: Treatment Group - Counseling<br>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. | Behavioral: Counseling<br>* Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Child Cotinine Levels in Urine | 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). | From Baseline to Week 26 Follow-Up | 
| Comparison of Questionnaire Results | Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables. | Baseline, Week 16 and Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoke-free, tobacco exposure, biomarker feedback, nicotine, cotinine, secondhand smoke