NCT01497158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

4.7 years

First QC Date

December 20, 2011

Last Update Submit

August 21, 2014

Conditions

Keywords

tobacco cessation

Outcome Measures

Primary Outcomes (2)

  • Comparison of Self-Reported Home Smoking Restrictions - Active Counseling

    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

    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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.

Other: Self-help brochure

Active Group

ACTIVE COMPARATOR

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 brochureOther: Biomarker feedback

Interventions

Self help brochure given at baseline visit.

Active GroupControl Group

Biomarker feedback from urine of adult non-smoker in the home.

Active Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455', United States

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use DisorderTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Janet Thomas, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

June 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations