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临床试验/NCT02512913
NCT02512913已完成不适用

Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity

Michigan State University1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2015年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
324
试验地点
1
主要终点
maternal smoking abstinence (questionnaire, biochemical verified)

研究概览

简要总结

The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component.

详细描述

Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes.

Building on ongoing pilot work led by Dr. Meghea with Babes-Bolyai University (BBU) in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same target population as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component.

The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania.

The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction.

This study will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline.

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

  • •the woman is pregnant,
  • •she is a smoker
  • •18 years or older (legal age for consent and for consuming tobacco in Romania)
  • •married or in a stable relationship
  • •phone service in the home or mobile phone
  • •willing to have the partner contacted for participation, upon brief explanation of the study.

排除标准

  • 未提供

研究组 & 干预措施

Adapted/enhanced MAPS

Experimental

Counseling sessions delivered by phone to the pregnant/postpartum women and to the husbands/partners

干预措施: Adapted/enhanced MAPS (Behavioral)

Usual Care

No Intervention

Couples in the control condition will receive usual care

结局指标

主要结局

maternal smoking abstinence (questionnaire, biochemical verified)

时间窗: assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth

assessed at multiple time points during the project

次要结局

  • maternal smoking abstinence (questionnaire)(assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristian Meghea

Assistant Professor

Michigan State University

研究点 (1)

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