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Completed

NCT Number: NCT01574560

P60 Program Project Grant-Outreach for Smoke-Free Homes

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Cessation Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brochure

Behavioral

Information regarding secondhand smoke and creating a healthy home environment.

Counseling

Behavioral

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

Primary outcomes

  1. Change in Home Secondhand Smoke levels

    Time frame: 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 outcomes

  1. Comparison of Child Cotinine Levels in Urine

    Time frame: 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).

  2. Comparison of Questionnaire Results

    Time frame: Baseline, Week 16 and Week 26

    Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Community Outreach and Biomarker Feedback for Smoke-Free Homes

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2012
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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