An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Seven-day point prevalence abstinence (PPA)
研究概览
简要总结
This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.
详细描述
The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •older than 18 years
- •gave up smoking 6 months before or during pregnancy
- •owns a smartphone
- •has a stable partner/husband
- •offers the partner's contact data
- •signs the informed consent
- •CO level (ppm) below 4
排除标准
- •younger than 18 years
- •does not own a smartphone
- •does not have a stable partner/husband
- •refuses to offer the partner's contact data
- •refuses to sign the informed consent
- •refuses the CO level measurement or the CO level (ppm) is above 4
结局指标
主要结局
Seven-day point prevalence abstinence (PPA)
时间窗: At 3 months post-birth
PPA, participants who reported 'no smoking, not even a puff' in the previous 7 days are mailed a saliva cotinine test and asked to send at least one photo of the completed test. Those with a salivary cotinine \<10 ng/mL, were considered confirmed nonsmokers.
Prolonged abstinence (PA)
时间窗: At 3 months post-birth
PA was defined based on the question "Have you smoked tobacco cigarettes over the past 6 months", with PA failure determined by the answers "Yes, I smoked, but never a whole cigarette," "Yes, I smoked cigarettes, but only occasionally," or "Yes, I smoked cigarettes daily for a period (or periods) of time."
次要结局
未报告次要终点
研究者
Cristian Ioan Meghea
Project Director
Babes-Bolyai University