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P60 Program Project Grant-Outreach for Smoke-Free Homes

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ClinicalTrials.gov Identifier: NCT01574560
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Cessation Behavioral: Brochure Behavioral: Counseling Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community Outreach and Biomarker Feedback for Smoke-Free Homes
Study Start Date : January 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group - Health Education
This group is provided with information regarding secondhand smoke and creating a healthy home environment.
 Behavioral: Brochure
Information regarding secondhand smoke and creating a healthy home environment.
Active Comparator: 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.
 Behavioral: Counseling
Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574560


Locations
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United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Janet L. Thomas, Ph.D. Masonic Cancer Center, University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01574560    
Other Study ID Numbers: 2009NTLS058
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Keywords provided by University of Minnesota:
smoke-free
tobacco exposure
biomarker feedback
 nicotine
cotinine
secondhand smoke