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'Questions About Quitting' Smoking Cessation Trial (Q2)

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00992264
First received: October 7, 2009
Last updated: August 21, 2014
Last verified: August 2014
History of Changes

October 7, 2009
August 21, 2014
May 2010
November 2012   (final data collection date for primary outcome measure)
  • Smoking Abstinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    7 day point prevalent abstinence
  • Treatment Utilization for Smoking Cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
  • Tobacco Use [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
  • Treatment Utilization for Smoking Cessation [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00992264 on ClinicalTrials.gov Archive Site
Not Provided
  • Quit Attempts [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
  • Motivation to Quit Smoking [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
'Questions About Quitting' Smoking Cessation Trial
Optimizing an Online Motivational Tobacco Cessation Program

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Smoking
  • 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.
  • 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.
  • Behavioral: Proactive Outreach
    Persons receive periodic, proactively delivered email reminders to visit the intervention website.
  • Behavioral: Testimonials
    People receive a personally-tailored testimonial as part of their online smoking cessation program.
  • Experimental: Message Tone

    Prescriptive or Motivational

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

    Intervention: Behavioral: Message Tone
  • Experimental: Testimonials
    Persons are randomized to receive a personally tailored testimonial or not.
    Intervention: Behavioral: Testimonials
  • 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.

    Intervention: Behavioral: Navigation
  • Experimental: Proactive Outreach

    Email or No-Email communication

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

    Intervention: Behavioral: Proactive Outreach

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1865
November 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00992264
R01CA138598
No
Group Health Cooperative
Group Health Cooperative
University of Michigan
Principal Investigator: Jennifer B McClure, PhD Group Health Research Institute
Group Health Cooperative
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP