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NCT00169260 Clinical Trial

Proactive Health Intervention for Tobacco Users (Get PHIT)

Smoking Clinical Trial

Official title:
Proactive Cessation Intervention With Biomarker Feedback

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169260
Other study ID # 5R01CA100341-02
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 2005
Est. completion date February 2010

Study information
Verified date August 2018
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 536
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• motivational counseling
behavioral motivational counselling
• placebo

Locations
Country Name City State
United States Group Health Cooperative Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Motivation to quit smoking, utilization of available resources, smoking cessation rate 1 year
Secondary Measurement of emotional distress, and mediators/moderators of primary outcomes 1 year
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