'Questions About Quitting' Smoking Cessation Trial

NCT00992264 | Completed Results

• 1 other identifier: R01CA138598
• Study Type: interventional
• Target: 1,865
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Cigarette Smoking; Health Behavior; Intervention Studies; Personal Communication

Outcome Measures

Primary Outcomes (2)

• Smoking Abstinence

  7 day point prevalent abstinence

  12 months

• Treatment Utilization for Smoking Cessation

  confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program

  12 months

Study Arms (4)

Message Tone

EXPERIMENTAL

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

Behavioral: Message Tone

Testimonials

EXPERIMENTAL

Persons are randomized to receive a personally tailored testimonial or not.

Behavioral: Testimonials

Navigation

EXPERIMENTAL

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.

Behavioral: Navigation

Proactive Outreach

EXPERIMENTAL

Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not.

Behavioral: Proactive Outreach

Interventions

Message Tone BEHAVIORAL

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.

Message Tone

Navigation BEHAVIORAL

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.

Navigation

Proactive Outreach BEHAVIORAL

Persons receive periodic, proactively delivered email reminders to visit the intervention website.

Proactive Outreach

Testimonials BEHAVIORAL

People receive a personally-tailored testimonial as part of their online smoking cessation program.

Testimonials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of Group Health Cooperative
• Currently Smoking at Least 5 Cigarettes/Day
• Access to Email and the Internet
• Read and Write English
• years or older
• Not currently receiving tobacco cessation treatment
• Capable of participating in online and phone surveys

You may not qualify if:

• Persons will be excluded if they do not meet above criteria

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of Michigan: collaborator

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• 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.

  PMID: 22771577 BACKGROUND

• 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.

  PMID: 23529377 RESULT

• 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.

  PMID: 24727369 RESULT

• 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.

  PMID: 24263289 DERIVED

MeSH Terms

Conditions

Smoking; Cigarette Smoking; Health Behavior; Communication

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Limitations and Caveats

The study was powered to detect differences between each factor level of 5% or more.

Results Point of Contact

• Title: Jennifer McClure
• Organization: Group Health Research Institute

mcclure.j@ghc.org

206-287-2737

Study Officials

• Jennifer B McClure, PhD

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 9, 2009
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: October 13, 2017
• Results First Posted: August 15, 2014

Record last verified: 2017-10

Locations

US (1)