Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 2
- 主要终点
- Percent of participants with cotinine verified 7-day point prevalence abstinence
研究概览
简要总结
The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy [i.e., nicotine replacement therapies (NRT)], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
详细描述
We will conduct a two-arm randomized controlled trial among Latinos who smoke and do not meet the recommended levels of physical activity (N=408). Participants will be recruited via community-based efforts and randomly assigned in a 1:1 ratio to Actívatexto (a mobile intervention that promotes both smoking cessation and physical activity) or Decídetexto (a mobile intervention that solely promotes smoking cessation). All participants will be provided with nicotine replacement therapies and a Fitbit Versa 4 device. Participants in both groups will complete a baseline assessment at enrollment and follow-up assessments at Months 3 and 6.
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
- Double (Investigator, Outcomes Assessor)
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
- •Self-identify as Hispanic and/or Latino
- •Know how to read and speak English and/or Spanish
- •Be ≥ 18 years of age
- •Not meet the recommended levels of physical activity (150 minutes of moderate to vigorous physical activity)
- •Smoke cigarettes at least 3 days per week
- •Be interested in quitting smoking in the next 30 days
- •Have a cellphone with text messaging capability
- •Know how to utilize text messages
- •Be willing to wear a wearable device daily to monitor physical activity
- •Be willing to complete all study visits
排除标准
- •Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)
- •Being pregnant or breastfeeding
- •Plan to move from their current residence in the next six months
- •Another household member enrolled in the study
- •Unable to become more physically active or engage in a fitness appraisal
研究组 & 干预措施
Actívatexto
Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
干预措施: Actívatexto (Behavioral)
Decídetexto
Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program.
干预措施: Decídetexto (Behavioral)
结局指标
主要结局
Percent of participants with cotinine verified 7-day point prevalence abstinence
时间窗: Month 6
Cotinine levels ≤15 ng/mL in saliva
次要结局
- Percent of participants with self-reported 7-day point prevalence abstinence(Month 6)
研究者
Francisco Cartujano, MD
Assistant Professor
University of Rochester