'Questions About Quitting' Smoking Cessation Trial (Q2)

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00992264
First received: October 7, 2009
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Message Tone
Behavioral: Navigation
Behavioral: Proactive Outreach
Behavioral: Testimonials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimizing an Online Motivational Tobacco Cessation Program

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    7 day point prevalent abstinence

  • Treatment Utilization for Smoking Cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program


Enrollment: 1865
Study Start Date: May 2010
Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Message Tone

Prescriptive or Motivational

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

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.
Experimental: Testimonials
Persons are randomized to receive a personally tailored testimonial or not.
Behavioral: Testimonials
People receive a personally-tailored testimonial as part of their online smoking cessation program.
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.

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.
Experimental: Proactive Outreach

Email or No-Email communication

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

Behavioral: Proactive Outreach
Persons receive periodic, proactively delivered email reminders to visit the intervention website.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: April 4, 2014
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014