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Proactive Health Intervention for Tobacco Users (Get PHIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00169260
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 29, 2010
Sponsor:
Information provided by:
Kaiser Permanente

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

Condition or disease Intervention/treatment Phase
Smoking Behavioral: motivational counseling Behavioral: placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proactive Cessation Intervention With Biomarker Feedback
Study Start Date : February 2005
Primary Completion Date : February 2010
Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1
Intervention
Behavioral: motivational counseling
behavioral motivational counselling
Placebo Comparator: 2
Control
Behavioral: placebo



Primary Outcome Measures :
  1. Motivation to quit smoking, utilization of available resources, smoking cessation rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Measurement of emotional distress, and mediators/moderators of primary outcomes [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169260


Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Jennifer B McClure, Ph.D. Kaiser Permanente