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
  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:


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 April 17, 2014