P60 Program Project Grant-Outreach for Smoke-Free Homes

August 5, 2014 updated by: University of Minnesota

Community Outreach and Biomarker Feedback 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 26 Follow-Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From Baseline to Week 26 Follow-Up
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.
Baseline, Week 16 and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Janet L. Thomas, Ph.D., Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009NTLS058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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