'Questions About Quitting' Smoking Cessation Trial (Q2)
October 11, 2017 updated by: Kaiser Permanente
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
1865
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Group Health Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Message Tone
Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational 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.
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EXPERIMENTAL: Testimonials
Persons are randomized to receive a personally tailored testimonial or not.
|
People receive a personally-tailored testimonial as part of their online smoking cessation program.
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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. |
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.
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EXPERIMENTAL: Proactive Outreach
Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not. |
Persons receive periodic, proactively delivered email reminders to visit the intervention website.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Abstinence
Time Frame: 12 months
|
7 day point prevalent abstinence
|
12 months
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Treatment Utilization for Smoking Cessation
Time Frame: 12 months
|
confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer B McClure, PhD, Group Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (ESTIMATE)
October 9, 2009
Study Record Updates
Last Update Posted (ACTUAL)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- R01CA138598 (NIH)
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