'Questions About Quitting' Smoking Cessation Trial (Q2)

Tracking Information
First Submitted Date ICMJE	October 7, 2009
First Posted Date ICMJE	October 9, 2009
Results First Submitted Date	April 4, 2014
Results First Posted Date	August 15, 2014
Last Update Posted Date	October 13, 2017
Study Start Date ICMJE	May 2010
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 13, 2014)	Smoking Abstinence [ Time Frame: 12 months ]7 day point prevalent abstinence; Treatment Utilization for Smoking Cessation [ Time Frame: 12 months ]confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
Original Primary Outcome Measures ICMJE; (submitted: October 8, 2009)	Tobacco Use [ Time Frame: 2, 6, 12 months ]; Treatment Utilization for Smoking Cessation [ Time Frame: 2, 6, 12 months ]
Change History	Complete list of historical versions of study NCT00992264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: October 8, 2009)	Quit Attempts [ Time Frame: 2, 6, 12 months ]; Motivation to Quit Smoking [ Time Frame: 2, 6, 12 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	'Questions About Quitting' Smoking Cessation Trial
Official Title ICMJE	Optimizing an Online Motivational Tobacco Cessation Program
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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Smoking
Intervention ICMJE	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.
Study Arms	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
Publications *	McClure JB, Derry H, Riggs KR, Westbrook EW, St John J, Shortreed SM, Bogart A, An LC. Questions about quitting (Q2): design and methods of a Multiphase Optimization Strategy (MOST) randomized screening experiment for an online, motivational smoking cessation intervention. Contemp Clin Trials. 2012 Sep;33(5):1094-102. doi: 10.1016/j.cct.2012.06.009. Epub 2012 Jul 4. Erratum in: Contemp Clin Trials. 2013 May;35(1):179-80.; McClure JB, Shortreed SM, Bogart A, Derry H, Riggs K, St John J, Nair V, An L. The effect of program design on engagement with an internet-based smoking intervention: randomized factorial trial. J Med Internet Res. 2013 Mar 25;15(3):e69. doi: 10.2196/jmir.2508.; McClure JB, Peterson D, Derry H, Riggs K, Saint-Johnson J, Nair V, An L, Shortreed SM. Exploring the "active ingredients" of an online smoking intervention: a randomized factorial trial. Nicotine Tob Res. 2014 Aug;16(8):1129-39. doi: 10.1093/ntr/ntu057. Epub 2014 Apr 11.; Shortreed SM, Bogart A, McClure JB. Using multiple imputations to accommodate time-outs in online interventions. J Med Internet Res. 2013 Nov 21;15(11):e252. doi: 10.2196/jmir.2781.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 22, 2011)	1865
Original Estimated Enrollment ICMJE; (submitted: October 8, 2009)	1840
Actual Study Completion Date	November 2013
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00992264
Other Study ID Numbers ICMJE	R01CA138598( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kaiser Permanente
Study Sponsor ICMJE	Kaiser Permanente
Collaborators ICMJE	University of Michigan
Investigators ICMJE	Principal Investigator: Jennifer B McClure, PhD Group Health Research Institute
PRS Account	Kaiser Permanente
Verification Date	October 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP