Evaluating Digital Health Interventions To Promote Smoking Cessation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 204
- Locations
- 2
- Primary Endpoint
- Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
Time Frame: 8 weeks
7-day PPA at end of treatment with be confirmed via cotinine testing in saliva
Secondary Outcomes
- Percent days smoke-free(up to 8 weeks)
- Change in cigarettes smoked per day(baseline, 4 weeks and 8 weeks)
- Average number of days to relapse(2 weeks post quit date)
- Treatment satisfaction assessed using the Mobile Application Rating Scale User version(up to 8 weeks)