P60 Program Project Grant-Outreach for Smoke-Free Homes

Smoking Cessation Clinical Trial

Official title:

Community Outreach and Biomarker Feedback for Smoke-Free Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574560
• Other study ID #: 2009NTLS058
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: August 5, 2014
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Cessation

Intervention

Behavioral:
• Brochure
Information regarding secondhand smoke and creating a healthy home environment.
• Counseling
Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Home Secondhand Smoke levels	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	No
Secondary	Comparison of Child Cotinine Levels in Urine	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	No
Secondary	Comparison of Questionnaire Results	Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.	Baseline, Week 16 and Week 26	No