Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

Study Overview
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Brief Summary
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This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.

Detailed Description
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This study is comprised of 2 active phases, all conducted with registered users on BecomeAnEX.org, a well-established smoking cessation website. Phase I involves the initial development and optimization of the text message intervention. The investigators will examine the impact of 4 experimental text message intervention features on smokers' adherence to a web-based cessation intervention during the first 3 months of program enrollment. The investigators will utilize a full factorial design where participants will be randomized to 1 of 2 levels of each of the following features: 1) personalization (yes/no), 2) integration (yes/no), 3) dynamic tailoring (yes/no), and 4) message intensity (standard vs. decreasing). The primary outcome in Phase I will be a composite metric of utilization. Phase II involves a 2-arm randomized trial that compares WEB alone to WEB plus the text message intervention from Phase I that yields optimal adherence (WEB+OA_TXT). The randomized trial will use a repeated measures design, with assessments at baseline, 3, 9, and 15 months. Follow-ups at 3, 9, and 15 months correspond to 0, 6, and 12 months post-treatment. The primary outcome is 30-day point prevalence abstinence (ppa) at 9-months. The investigators will assess and validate smoking status at all follow-ups. Other outcomes include motivation to quit, quit attempts, and continuous abstinence.

Official Title
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Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Personalization
* Behavioral: Integration
* Behavioral: Dynamic Tailoring
* Behavioral: Message Intensity
* Behavioral: Optimal-Adherence Text


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US residency Current smoker Access to and willingness to receive text messages on a mobile phone Access to Internet Access to and willingness to receive email communication from study personnel Exclusion Criteria: None

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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Accepts Healthy Volunteers

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
Interventional Model Description: Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1<br>All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF | |
| Active Comparator: Arm 2<br>Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON | Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 3<br>Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF | Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>|
| Active Comparator: Arm 4<br>Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON | Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 5<br>Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF | Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>|
| Active Comparator: Arm 6<br>Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON | Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 7<br>Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF | Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>|
| Active Comparator: Arm 8<br>Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON | Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 9<br>Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>|
| Active Comparator: Arm 10<br>Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 11<br>Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>|
| Active Comparator: Arm 12<br>Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 13<br>Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>|
| Active Comparator: Arm 14<br>Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| Active Comparator: Arm 15<br>Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>|
| Active Comparator: Arm 16<br>Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON | Behavioral: Personalization<br>* Phase I Factor Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data.<br>Behavioral: Integration<br>* Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.<br>Behavioral: Dynamic Tailoring<br>* Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.<br>Behavioral: Message Intensity<br>* Phase I Factor Varying levels of text message intensity over a 12-week period.<br>|
| No Intervention: WEB<br>Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program. | |
| Active Comparator: WEB+OA_TXT<br>Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I. | Behavioral: Optimal-Adherence Text<br>* Optimal-adherence text message intervention developed in Phase I<br>* Other names: OA_TXT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I - Composite adherence metric | The investigators will create a composite metric of adherence for each Phase I participant using a weighted sum of their total number of number of visits, as well as of their page views, time on site, and use of the 6 interactive components of the site per visit during 3 months post-enrollment. | 3 months | 
| Phase II - 30-day point prevalence abstinence | Self-reported 30-day point prevalence abstinence at 9 months post randomization | 9 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II - 30day point prevalence abstinence | Self-reported 30-day point prevalence abstinence at 3 months post randomization | 3 months post randomization | 
| Phase II - 30day point prevalence abstinence | Self-reported 30-day point prevalence abstinence at 15 months post randomization | 15 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Phone, Text Messaging, Internet, Tobacco Use