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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored | Active Comparator | Tailored texting program for quit smoking |
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| Standard | Placebo Comparator | Standard texting program for quit smoking |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking Cessation Program | Other | A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test | Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days [not even a puff of cigarettes, cigars, hookah, or pipe tobacco] with a negative breath CO test ≤ 4 ppm). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants that are biochemically-confirmed 7-day abstinence | Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months | 1 and 3 months |
| Percent of participants that self-report 24-hour abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana Carroll, PhD | Contact | 612-624-0132 | dcarroll@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
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| Cultural Smoking Cessation Program | Other | A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons. |
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Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months
| 1, 3, and 6 months |
| Percent of participants that self-report 7-day abstinence | Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months | 1, 3, and 6 months |
| Percent of participants that self-report 30-day abstinence | Percent of participants that self-report 30-day abstinence at 3 and 6 months | 3 and 6 months |
| Mean cigarettes per day in past 7 days | Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months | 1, 3, and 6 months |
| Number of 24-hour quit attempts in past 30 days | Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months | 1, 3, and 6 months |
| Percent of participants that used nicotine replacement therapy and pharmacotherapy | Percent of participants that used nicotine replacement therapy and pharmacotherapy (e.g. nicotine patch, Chantix) in past 30 days at 1, 3, and 6 months | 1, 3, and 6 months |
| Percent of participants that used other behavioral support | Percent of participants that used other behavioral support (e.g. in-person, quitline) for smoking cessation in past 30 days at 1, 3, and 6 months | 1, 3, and 6 months |
| Percent of participants that used other commercial tobacco products | Percent of participants that used other commercial tobacco products (e.g., smokeless tobacco, e-cigarettes) in the past 7 days 1, 3, and 6 months | 1, 3, and 6 months |
| Mean cigarette dependence | mean cigarette dependence at 1, 3, and 6 months | 1, 3, and 6 months |