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| ID | Type | Description | Link |
|---|---|---|---|
| IA-1049344 | Other Grant/Funding Number | American Lung Association |
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| Name | Class |
|---|---|
| American Lung Association | OTHER |
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This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.
Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.
Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.
Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmokefreeTXT | Active Comparator | Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT. |
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| SmokefreeTXT + smartband | Experimental | Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmokefreeTXT | Other | National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks) | 7-day PPA at end of treatment with be confirmed via cotinine testing in saliva | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cigarettes smoked per day | Change in average number cigarettes smoked per day by self report | baseline, 4 weeks and 8 weeks |
| Percent days smoke-free | Percentage of smoke-free days by self report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen A Garrison, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National online recruitment | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Smartband | Device | A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight. |
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| up to 8 weeks |
| Average number of days to relapse | Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date. | 2 weeks post quit date |
| Treatment satisfaction assessed using the Mobile Application Rating Scale User version | This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. | up to 8 weeks |