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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019748 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Hackensack Meridian Health | OTHER |
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The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy [i.e., nicotine replacement therapies (NRT)], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
We will conduct a two-arm randomized controlled trial among Latinos who smoke and do not meet the recommended levels of physical activity (N=408). Participants will be recruited via community-based efforts and randomly assigned in a 1:1 ratio to Actívatexto (a mobile intervention that promotes both smoking cessation and physical activity) or Decídetexto (a mobile intervention that solely promotes smoking cessation). All participants will be provided with nicotine replacement therapies and a Fitbit Versa 4 device. Participants in both groups will complete a baseline assessment at enrollment and follow-up assessments at Months 3 and 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actívatexto | Experimental | Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices. |
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| Decídetexto | Active Comparator | Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actívatexto | Behavioral | Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with cotinine verified 7-day point prevalence abstinence | Cotinine levels ≤15 ng/mL in saliva | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with self-reported 7-day point prevalence abstinence | No cigarettes, "not even a puff", in the past 7 days | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Cartujano, MD | Contact | (585) 273-1646 | francisco_cartujano@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Decídetexto | Behavioral | Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program. |
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