Proactive Health Intervention for Tobacco Users (Get PHIT) - Full Text View

Purpose

The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.

Condition	Intervention	Phase
Smoking	Behavioral: motivational counseling Behavioral: placebo	Phase II Phase III

MedlinePlus related topics:

Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Proactive Cessation Intervention With Biomarker Feedback

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:

Motivation to quit smoking, utilization of available resources, smoking cessation rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurement of emotional distress, and mediators/moderators of primary outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	536
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Experimental Intervention	Behavioral: motivational counseling behavioral motivational counselling
2: Placebo Comparator Control	Behavioral: placebo

Detailed Description:

The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years old,
smoke greater than or equal to 15 cigarettes a day,
have an expired CO level greater than or equal to 10 ppm,
are not currently being treated for smoking cessation,
can read and write in English,
provide contact information,
agree to the study requirements,
have no medical contraindications for spirometry assessment,
and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study.

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169260

Locations


United States, Washington
	Group Health Cooperative
	Seattle, Washington, United States, 98101

Sponsors and Collaborators

Group Health Cooperative

Investigators


Principal Investigator:	Jennifer B McClure, Ph.D.	Group Health Cooperative

More Information

Responsible Party:	Group Health Center for Health Studies ( Jennifer McClure, Principal Investigator )
Study ID Numbers:	5 R01 CA100341-02
First Received:	September 12, 2005
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00169260
Health Authority:	United States: Federal Government

Keywords provided by Group Health Cooperative:

smoking

tobacco

behavior therapy

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Group Health Cooperative
Information provided by:	Group Health Cooperative
ClinicalTrials.gov Identifier:	NCT00169260