Postnatal Smoking Relapse, Its Associated Risk Factors, and a Proactive Sustainable Preventive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- Postpartum maternal smoking abstinence
研究概览
简要总结
This study will assess the extent of postpartum smoking relapse among Romanian women, the associated risk factors, and will develop, implement, and pilot-test a randomized trial smoking relapse intervention incorporating innovative research concepts in a social and cultural acceptable manner. The primary hypothesis is that the intervention will increase mothers' smoking abstinence rates.
详细描述
Overview.
This four-year longitudinal project will enroll a total of 425 women who spontaneously quit smoking during pregnancy. The recruitment will take place during the delivery hospital stay in two of the largest obstetric-gynecology hospitals in Cluj-Napoca, Romania. The investigators will design, pre-test (Objective 1), apply, and evaluate a postpartum smoking relapse preventive randomized intervention among the first 250 recruited women and their husbands (Objective 2): 125 couples in the intervention group and 125 couples in the control group, comparing the women's relapse rates at 6 months postpartum. The project will continue to enroll and follow-up 175 additional women for a total of 300 not subjected to the intervention (125+175) to assess the extent of postpartum smoking relapse and associated risk factors in a prospective cohort study (Objective 3).
The work plan.
The first 6 months of the project consisted of a preparatory phase. Objective 1 was completed in the first 9 months of the project, and milestones included focus groups, interviews with women, their husbands, and medical staff, the design of the intervention and pre-testing its acceptability. Objective 2 is completed between months 10-24 of the project. Milestones include: recruiting 250 couples (months 10-30), applying the intervention (months 10-33), the follow-up assessment (months 16-36), and preliminary analyses (months 13-36). Objective 3 is completed between months 19-45 of the project. Milestones include: recruiting 175 additional women (months 19-39), the follow-up assessment (months 25-45), and preliminary analyses (months 22-45). The last 12 months (months 37-48) of the project will be used to conclude the project, including finalizing the database and analyses, preparing a final report, and preparing articles for publication.
Objective 1: Design, pre-test, and refine an innovative intervention for preventing smoking relapse after pregnancy to maximize feasibility and potential impact.
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
- Triple (Participant, 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
- 是
入选标准
- •Willingness and ability to participate in the study
- •Married or living with a stable partner
- •Mobile phone
- •Willing to provide mobile phone contact for their husband or partner
排除标准
- •Age<18 (minor age in Romania)
结局指标
主要结局
Postpartum maternal smoking abstinence
时间窗: 6 months postpartum
Defined as maintaining smoke-free status continuously until the 6-month follow-up. The postpartum maternal abstinence will be biochemically verified through expired carbon monoxide (CO) at 6-months postpartum
次要结局
- Self-reported smoke status of the husband/partner.(6 months postpartum)
- Maternal number of cigarettes smoked(6 months postpartum)
- Maternal self-efficacy scores on the Romanian version of the General Self Efficacy scale(6 months postpartum)
- Maternal motivation scores on the Reasons for Quitting scale(6 months postpartum)
研究者
Cristian Ioan Meghea
Scientific Researcher
Babes-Bolyai University