Smoking Cessation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSmokefreeTXT
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.
DEVICESmartband
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.
Sponsors
American Lung Association
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* daily smokers for at least 6 months * report an interest in quitting smoking.
Exclusion criteria
* reporting being currently enrolled in another quit smoking program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks) | 8 weeks | 7-day PPA at end of treatment with be confirmed via cotinine testing in saliva |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cigarettes smoked per day | baseline, 4 weeks and 8 weeks | Change in average number cigarettes smoked per day by self report |
| Percent days smoke-free | up to 8 weeks | Percentage of smoke-free days by self report |
| Average number of days to relapse | 2 weeks post quit date | 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. |
| Treatment satisfaction assessed using the Mobile Application Rating Scale User version | up to 8 weeks | 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. |
Countries
United States
Outcome results
None listed