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Community Outreach and Biomarker Feedback for Smoke-Free Homes


N/A
18 Years
N/A
Open (Enrolling)
Female
Smoking Cessation, Tobacco Cessation

Thank you

Trial Information

Community Outreach and Biomarker Feedback for Smoke-Free Homes


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change in Home Secondhand Smoke levels

Outcome Description:

Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.

Outcome Time Frame:

From Baseline to Week 26 Follow-Up

Safety Issue:

No

Principal Investigator

Janet L. Thomas, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2009NTLS058

NCT ID:

NCT01574560

Start Date:

January 2011

Completion Date:

April 2015

Related Keywords:

  • Smoking Cessation
  • Tobacco Cessation
  • smoke-free
  • tobacco exposure
  • biomarker feedback
  • nicotine
  • cotinine
  • secondhand smoke
  • Smoking

Name

Location

Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455