Evaluating Digital Health Interventions To Promote Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •daily smokers for at least 6 months
- •report an interest in quitting smoking.
排除标准
- •reporting being currently enrolled in another quit smoking program
结局指标
主要结局
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
时间窗: 8 weeks
7-day PPA at end of treatment with be confirmed via cotinine testing in saliva
次要结局
- 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)