P60 Program Project Grant-Outreach for Smoke-Free Homes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

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.

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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.

Conditions

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Smoking Cessation Tobacco Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group - Health Education

This group is provided with information regarding secondhand smoke and creating a healthy home environment.

Group Type ACTIVE_COMPARATOR

Brochure

Intervention Type BEHAVIORAL

Information regarding secondhand smoke and creating a healthy home environment.

Treatment Group - 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.

Group Type ACTIVE_COMPARATOR

Counseling

Intervention Type BEHAVIORAL

Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.

Interventions

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Brochure

Information regarding secondhand smoke and creating a healthy home environment.

Intervention Type BEHAVIORAL

Counseling

Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* \< 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes