Clinical trial NCT00992264: 'Questions About Quitting' Smoking Cessation Trial
Official title: Optimizing an Online Motivational Tobacco Cessation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Cigarette Smoking
Health Behavior
Intervention Studies
Personal Communication
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2009-10-09
Enrollment: 1865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 12 months
measure: Treatment Utilization for Smoking Cessation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: Jennifer B McClure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.