NCT01574560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

April 5, 2012

Last Update Submit

August 5, 2014

Conditions

Smoking CessationTobacco Cessation

Keywords

smoke-freetobacco exposurebiomarker feedbacknicotinecotininesecondhand smoke

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Comparison of Child Cotinine Levels in Urine

    From Baseline to Week 26 Follow-Up

  • Comparison of Questionnaire Results

    Baseline, Week 16 and Week 26

Study Arms (2)

Control Group - Health Education

ACTIVE COMPARATOR

This group is provided with information regarding secondhand smoke and creating a healthy home environment.

Behavioral: Brochure

Treatment Group - Counseling

ACTIVE COMPARATOR

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

Interventions

BrochureBEHAVIORAL

Information regarding secondhand smoke and creating a healthy home environment.

Control Group - Health Education
CounselingBEHAVIORAL

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

Treatment Group - Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \< 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Janet L. Thomas, Ph.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 10, 2012

Study Start

January 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

US(1)