NCT00169260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

September 12, 2005

Last Update Submit

August 9, 2018

Conditions

Smoking

Keywords

smokingtobaccobehavior therapy

Outcome Measures

Primary Outcomes (1)

  • Motivation to quit smoking, utilization of available resources, smoking cessation rate

    1 year

Secondary Outcomes (1)

  • Measurement of emotional distress, and mediators/moderators of primary outcomes

    1 year

Study Arms (2)

1

EXPERIMENTAL

Intervention

Behavioral: motivational counseling

2

PLACEBO COMPARATOR

Control

Behavioral: placebo

Interventions

motivational counselingBEHAVIORAL

behavioral motivational counselling

1
placeboBEHAVIORAL
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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.

    PMID: 20434863DERIVED

  • 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.

    PMID: 19524389DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer B McClure, Ph.D.

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(1)