'Questions About Quitting' Smoking Cessation Trial (Q2)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00992264

First Posted: October 9, 2009

Last Update Posted: October 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Michigan

Information provided by (Responsible Party):

Kaiser Permanente

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

Start Date ^ICMJE

May 2010

Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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 Provided

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 *

* 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

Enrollment ^ICMJE

1865

Completion Date

November 2013

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

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

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

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