Clinical trial NCT01574560: P60 Program Project Grant-Outreach for Smoke-Free Homes
Official title: Community Outreach and Biomarker Feedback for Smoke-Free Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Cessation
Keywords: smoke-free
tobacco exposure
biomarker feedback
nicotine
cotinine
secondhand smoke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Home Secondhand Smoke levels
timeFrame: From Baseline to Week 26 Follow-Up
Secondary outcomes:
measure: Comparison of Child Cotinine Levels in Urine
timeFrame: From Baseline to Week 26 Follow-Up
measure: Comparison of Questionnaire Results
timeFrame: Baseline, Week 16 and Week 26
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Janet L. Thomas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: