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The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sponsored cessation intervention | Experimental | Intervention arm receiving sponsored version only available for enterprise client users. |
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| Usual Care | Active Comparator | Usual care control arm receiving referral to a free digital cessation program |
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| Free cessation intervention | Experimental | Intervention arm receiving free version of a cessation intervention. |
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| Assessment-only | No Intervention | Periodic assessment check-ins only, no active intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truth Initiative Digital Cessation Program | Behavioral | Truth Initiative's digital cessation program is a multimodal evidence-based, digital tobacco cessation program. Accessible on any web-enabled device, it was developed with the Mayo Clinic around tobacco dependence treatment guidelines, Social Cognitive Theory, and the Mayo Clinic model for engaging tobacco users in cessation treatment. It includes a personalized quit plan with AI-driven content recommendations, interactive exercises, educational videos, and emails; a dynamically tailored, bidirectional text message program; the longest-running online community dedicated to tobacco cessation; synchronous live chat coaching (sponsored version only); and pharmacotherapy decision support and delivery (sponsored version only). |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day point prevalent abstinence | 30-day point prevalent abstinence from user's primary product to quit indicated at enrollment | 7-months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence from all tobacco products | Abstinence from any combustible tobacco product and any nicotine-containing product. Past 30-day abstinence will be measured for the following tobacco/nicotine products one by one and a combined total abstinence measure will be calculated based on these responses. Measurement item: In the past 30 days, which of the following products have you used at all (i.e., even a puff/hit)? Response options are Yes/No for each item.
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truth Initiative | Washington D.C. | District of Columbia | 20001 | United States |
Deidentified dataset will be available for replication purposes with a Data Sharing Agreement with Truth Initiative.
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Data collection staff will be blinded to study condition.
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| Usual Care | Behavioral | Smokefree.gov is a web-based tobacco cessation platform run by the National Cancer Institute of the National Institutes of Health since 2003 and represents the current standard of care for digital tobacco cessation in the U.S. As of 2020, the SmokeFree.gov Initiative (SFGI) consisted of a multimodal suite of interventions - 6 mobile-optimized websites, 9 text messaging programs, 2 mobile apps, and social media platforms. |
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| 7 months post randomization |