Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults

August 21, 2014 updated by: University of Minnesota

Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults

This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.

Study Type

Interventional

Enrollment (Actual)

122

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'
        • 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

All

Description

Inclusion Criteria:

  • Must be at least 18 years of age
  • Cohabitating Non-Smoker (control) and smoker (active)
  • Smoker must test > 6ppm on carbon dioxide (CO) test and non-smoker < 6ppm
  • General good health
  • Written informed consent
  • Live within Twin Cities 7 county metropolitan area (Minnesota)
  • Plan to live in same home for 6 months and be willing for researchers to come to their home

Exclusion Criteria:

  • Individuals that live in a treatment facility or shelter
  • Individuals endorsing current domestic violence

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.
Other: Self-help brochure
Self help brochure given at baseline visit.
Active Comparator: Active Group
Participants who received self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home and biomarker feedback from the urine of cohabitating adult non-smoker in the home.
Other: Self-help brochure
Self help brochure given at baseline visit.
Other: Biomarker feedback
Biomarker feedback from urine of adult non-smoker in the home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling
Time Frame: From baseline to week 12
Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
From baseline to week 12
Comparison of Self-Reported Home Smoking Restrictions - Control Group
Time Frame: From baseline to week 12
Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
From baseline to week 12

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Janet Thomas, M.D., 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

June 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007NT053

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.

Clinical Trials on Smoking Cessation

Clinical Trials on Self-help brochure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe