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Proactive Health Intervention for Tobacco Users (Get PHIT)

This study has been completed.
Sponsor:
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00169260
First received: September 12, 2005
Last updated: December 27, 2010
Last verified: December 2010
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proactive Cessation Intervention With Biomarker Feedback

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention
 Behavioral: motivational counseling
behavioral motivational counselling
Placebo Comparator: 2
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

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jennifer McClure, Principal Investigator, Group Health Research Institute
ClinicalTrials.gov Identifier: NCT00169260     History of Changes
Other Study ID Numbers: 5 R01 CA100341-02
Study First Received: September 12, 2005
Last Updated: December 27, 2010
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
smoking
tobacco
behavior therapy

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013