Proactive Health Intervention for Tobacco Users (Get PHIT)

NCT ID: NCT00169260

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intervention

Group Type EXPERIMENTAL

motivational counseling

Intervention Type BEHAVIORAL

behavioral motivational counselling

2

Control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BEHAVIORAL

Interventions

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motivational counseling

behavioral motivational counselling

Intervention Type BEHAVIORAL

placebo

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer B McClure, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Group Health Cooperative

Seattle, Washington, United States

Site Status

Countries

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United States

References

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McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of spirometry feedback and brief motivational counseling on long-term smoking outcomes: a comparison of smokers with and without lung impairment. Patient Educ Couns. 2010 Aug;80(2):280-3. doi: 10.1016/j.pec.2009.11.002.

Reference Type DERIVED
PMID: 20434863 (View on PubMed)

McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Am J Prev Med. 2009 Aug;37(2):116-23. doi: 10.1016/j.amepre.2009.03.018. Epub 2009 Jun 12.

Reference Type DERIVED
PMID: 19524389 (View on PubMed)

Other Identifiers

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5R01CA100341-02

Identifier Type: NIH

Identifier Source: org_study_id

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