Mobile Health Intervention for Family Smoking Cessation in Romania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
研究概览
简要总结
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
- •18 years or older
- •married or in a stable relationship
- •owns and uses an Android smartphone with broadband internet connection
- •willing to have the partner contacted for participation.
排除标准
- 未提供
研究组 & 干预措施
Telemedicine counseling only
The intervention will consist of participants will only use telemedicine counseling
干预措施: Smoke Free Together - Telemedicine counseling only (Behavioral)
App + telemedicine counseling
The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling
干预措施: Smoke Free Together - app + telemedicine (Behavioral)
App-only
The intervention will consist of participants will only use a smoking cessation app
干预措施: Smoke Free Together - App-only (Behavioral)
Usual Care
The participants will continue with usual care
结局指标
主要结局
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
时间窗: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
The primary outcomes are maternal pregnancy smoking cessation and postnatal relapse. Maternal smoking status will be biochemically verified at the final follow-up based on salivary cotinine obtained by mail.
次要结局
未报告次要终点
研究者
Cristian Meghea
Assistant Professor
Michigan State University