'Questions About Quitting' Smoking Cessation Trial

Smoking Clinical Trial

— Q2  

Official title:

Optimizing an Online Motivational Tobacco Cessation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992264
• Other study ID #: R01CA138598
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 11, 2017
• Start date: May 2010
• Est. completion date: November 2013

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1865
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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.
• 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.
• Proactive Outreach
Persons receive periodic, proactively delivered email reminders to visit the intervention website.
• Testimonials
People receive a personally-tailored testimonial as part of their online smoking cessation program.

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. E — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	7 day point prevalent abstinence	12 months
Primary	Treatment Utilization for Smoking Cessation	confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program	12 months