'Questions About Quitting' Smoking Cessation Trial

Study Overview
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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.

Official Title
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Optimizing an Online Motivational Tobacco Cessation Program

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Message Tone
* Behavioral: Navigation
* Behavioral: Proactive Outreach
* Behavioral: Testimonials


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Message Tone<br>Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone. | Behavioral: Message Tone<br>* 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.<br>|
| Experimental: Testimonials<br>Persons are randomized to receive a personally tailored testimonial or not. | Behavioral: Testimonials<br>* People receive a personally-tailored testimonial as part of their online smoking cessation program.<br>|
| Experimental: Navigation<br>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<br>* 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.<br>|
| Experimental: Proactive Outreach<br>Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not. | Behavioral: Proactive Outreach<br>* Persons receive periodic, proactively delivered email reminders to visit the intervention website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | 7 day point prevalent abstinence | 12 months | 
| Treatment Utilization for Smoking Cessation | confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette Smoking, Health Behavior, Intervention Studies, Personal Communication