Optimizing an Online Motivational Tobacco Cessation Program

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of Michigan

Information provided by (Responsible Party):

Group Health Cooperative

ClinicalTrials.gov Identifier:

NCT00992264

First received: October 7, 2009

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2009

Last Updated Date

September 11, 2012

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Tobacco Use [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
Treatment Utilization for Smoking Cessation [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00992264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quit Attempts [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
Motivation to Quit Smoking [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optimizing an Online Motivational Tobacco Cessation Program

Official Title ^ICMJE

Optimizing an Online Motivational Tobacco Cessation Program

Brief Summary

The current study will test the effectiveness of five potentially important tailoring factors (decisional framework, message framing, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. Information learned from this study will advance the science of tailoring health risk communications, as well as inform how to best design an online motivational intervention for smoking cessation. Participants in this study will be recruited from a large, regional U.S. health plan. Using a fractional factorial design to screen for important main effects and 2-way interactions, participants will be randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' motivation for quitting, use of empirically-validated cessation treatment, and abstinence.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Smoking

Intervention ^ICMJE

Behavioral: personally-tailored, online tobacco cessation intervention

Using a fractional factorial design to screen for important main effects and 2-way interactions,participants will be randomized to receive one of 16 different experimental factor combinations of the intervention

Study Arm (s)

Experimental: Decisional Framework
Prescriptive or Non-Directive

Intervention: Behavioral: personally-tailored, online tobacco cessation intervention
Experimental: Message Framing
Gain Framed or Loss Framed

Intervention: Behavioral: personally-tailored, online tobacco cessation intervention
Experimental: Self-efficacy
Low-Tailored or High-Tailored

Intervention: Behavioral: personally-tailored, online tobacco cessation intervention
Experimental: Navigation
Dictated or Non-Dictated

Intervention: Behavioral: personally-tailored, online tobacco cessation intervention
Experimental: Proactive Outreach
Email or No-Email communication

Intervention: Behavioral: personally-tailored, online tobacco cessation intervention

Publications *

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.

* 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

Active, not recruiting

Enrollment ^ICMJE

1865

Estimated Completion Date

November 2012

Estimated 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00992264

Other Study ID Numbers ^ICMJE

R01CA138598

Has Data Monitoring Committee

Responsible Party

Group Health Cooperative

Study Sponsor ^ICMJE

Group Health Cooperative

Collaborators ^ICMJE

University of Michigan

Investigators ^ICMJE

Principal Investigator:

Jennifer B McClure, PhD

Group Health Research Institute

Information Provided By

Group Health Cooperative

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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