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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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing an Online Motivational Tobacco Cessation Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1865
Study Start Date: May 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decisional Framework
Prescriptive or Non-Directive
 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
Experimental: Message Framing
Gain Framed or Loss Framed
 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
Experimental: Self-efficacy
Low-Tailored or High-Tailored
 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
Experimental: Navigation
Dictated or Non-Dictated
 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
Experimental: Proactive Outreach
Email or No-Email communication
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992264

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
University of Michigan
Investigators
Principal Investigator: Jennifer B McClure, PhD Group Health Research Institute
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00992264     History of Changes
Other Study ID Numbers: R01CA138598
Study First Received: October 7, 2009
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Cigarette Smoking
Health Behavior
Intervention Studies
Personal Communication

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013