Smoking Cessation, Tobacco Cessation
Conditions
Keywords
smoke-free, tobacco exposure, biomarker feedback, nicotine, cotinine, secondhand smoke
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.
Interventions
BEHAVIORALBrochure
Information regarding secondhand smoke and creating a healthy home environment.
BEHAVIORALCounseling
Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed