'Questions About Quitting' Smoking Cessation Trial (Q2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992264
Recruitment Status : Completed
First Posted : October 9, 2009
Results First Posted : August 15, 2014
Last Update Posted : October 13, 2017
University of Michigan
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Message Tone Behavioral: Navigation Behavioral: Proactive Outreach Behavioral: Testimonials Not Applicable

Detailed Description:
The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1865 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing an Online Motivational Tobacco Cessation Program
Study Start Date : May 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Message Tone

Prescriptive or Motivational

Persons are randomized to receive intervention content written in either a prescriptive or motivational tone.

Behavioral: Message Tone
All participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone.

Experimental: Testimonials
Persons are randomized to receive a personally tailored testimonial or not.
Behavioral: Testimonials
People receive a personally-tailored testimonial as part of their online smoking cessation program.

Experimental: Navigation

Dictated or Non-Dictated

Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking.

Behavioral: Navigation
Persons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website.

Experimental: Proactive Outreach

Email or No-Email communication

Persons are randomized to receive periodic email reminders to return to the intervention website or not.

Behavioral: Proactive Outreach
Persons receive periodic, proactively delivered email reminders to visit the intervention website.

Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 12 months ]
    7 day point prevalent abstinence

  2. Treatment Utilization for Smoking Cessation [ Time Frame: 12 months ]
    confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Member of Group Health Cooperative
  • Currently Smoking at Least 5 Cigarettes/Day
  • Access to Email and the Internet
  • Read and Write English
  • 18 years or older
  • Not currently receiving tobacco cessation treatment
  • Capable of participating in online and phone surveys

Exclusion Criteria:

  • Persons will be excluded if they do not meet above criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992264

United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
University of Michigan
Principal Investigator: Jennifer B McClure, PhD Group Health Research Institute

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kaiser Permanente Identifier: NCT00992264     History of Changes
Other Study ID Numbers: R01CA138598 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2009    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Cigarette Smoking
Health Behavior
Intervention Studies
Personal Communication