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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF | |
| Arm 2 | Active Comparator | Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON |
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| Arm 3 | Active Comparator | Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF |
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| Arm 4 | Active Comparator | Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON |
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| Arm 5 | Active Comparator | Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF |
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| Arm 6 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalization | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda L Graham, PhD | Truth Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truth Initiative | Washington D.C. | District of Columbia | 20001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27029775 | Background | Graham AL, Jacobs MA, Cohn AM, Cha S, Abroms LC, Papandonatos GD, Whittaker R. Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. BMJ Open. 2016 Mar 30;6(3):e010687. doi: 10.1136/bmjopen-2015-010687. | |
| 34472676 | Derived | Graham AL, Papandonatos GD, Cha S, Amato MS, Jacobs MA, Cohn AM, Abroms LC, Whittaker R. Effectiveness of an optimized text message and Internet intervention for smoking cessation: A randomized controlled trial. Addiction. 2022 Apr;117(4):1035-1046. doi: 10.1111/add.15677. Epub 2021 Sep 28. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
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Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON
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| Arm 7 | Active Comparator | Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF |
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| Arm 8 | Active Comparator | Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON |
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| Arm 9 | Active Comparator | Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF |
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| Arm 10 | Active Comparator | Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON |
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| Arm 11 | Active Comparator | Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF |
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| Arm 12 | Active Comparator | Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON |
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| Arm 13 | Active Comparator | Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF |
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| Arm 14 | Active Comparator | Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON |
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| Arm 15 | Active Comparator | Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF |
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| Arm 16 | Active Comparator | Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON |
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| WEB | No Intervention | Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program. |
| WEB+OA_TXT | Active Comparator | Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I. |
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| Integration | Behavioral | 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. |
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| Dynamic Tailoring | Behavioral | 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. |
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| Message Intensity | Behavioral | Phase I Factor Varying levels of text message intensity over a 12-week period. |
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| Optimal-Adherence Text | Behavioral | Optimal-adherence text message intervention developed in Phase I |
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Self-reported 30-day point prevalence abstinence at 15 months post randomization
| 15 months post randomization |
| 32238338 | Derived | Graham AL, Papandonatos GD, Jacobs MA, Amato MS, Cha S, Cohn AM, Abroms LC, Whittaker R. Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment. J Med Internet Res. 2020 Apr 2;22(4):e17734. doi: 10.2196/17734. |