'Questions About Quitting' Smoking Cessation Trial

NCT ID: NCT00992264

Last Updated: 2017-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1865 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Smoking

Keywords

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Cigarette Smoking Health Behavior Intervention Studies Personal Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Message Tone

Prescriptive or Motivational

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

Group Type EXPERIMENTAL

Message Tone

Intervention Type 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.

Testimonials

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

Group Type EXPERIMENTAL

Testimonials

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Navigation

Intervention Type 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.

Proactive Outreach

Email or No-Email communication

Persons are randomized to receive periodic email reminders to return to the intervention website or not.

Group Type EXPERIMENTAL

Proactive Outreach

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Proactive Outreach

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

Intervention Type BEHAVIORAL

Testimonials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer B McClure, PhD

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22771577 (View on PubMed)

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.

Reference Type RESULT
PMID: 23529377 (View on PubMed)

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.

Reference Type RESULT
PMID: 24727369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24263289 (View on PubMed)

Other Identifiers

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R01CA138598

Identifier Type: NIH

Identifier Source: org_study_id

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