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临床试验/NCT01684592
NCT01684592已完成不适用

Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy

Battelle Memorial Institute4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年10月最近更新:
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
130
试验地点
4
主要终点
Number of Tobacco Products Per Day

研究概览

简要总结

Smoking is a leading cause of death and other negative health outcomes. While a high percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months postpartum. We propose developing and pilot testing a phone-based postpartum continuing care (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation, reduce relapse, increase early re-intervention, and reduce infant exposure to environmental tobacco smoke in the postpartum period.

详细描述

The large majority of women who quit smoking during pregnancy relapse in the first six months postpartum, highlighting a need for effective postpartum continuing care that supports women through the challenging postpartum period when stress is high and motivation to stay quit may decline. Existing relapse prevention interventions (typically delivered during pregnancy) have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols for smoking cessation have been widely disseminated and effective because they address the need for flexible access, but are passive and not typically utilized by women in the postpartum period.

The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery Management Checkups (RMC)-- shown to be effective with other populations. The experimental PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women are more likely to relapse, and provide education and monitoring of the infant's direct and indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current standard care.

Approximately one hundred thirty women in their first or second trimester of pregnancy who were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in Baltimore, Maryland. All women will receive the clinic's standard of care for smoking cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned to an experimental group getting PPCC for 6 months postpartum and half to a control group receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that in the 6 months following childbirth women in the experimental PPCC (relative to those in the control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before postpartum relapse, d) have less time between relapse and talking to a health professional about smoking, e) have less time between relapse and resumption of abstinence , f) smoke fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant, and h) reduce their infant's cotinine levels.

The aims of this pilot project are to develop PPCC from existing evidence-based approaches, demonstrate the feasibility of implementing the PPCC intervention with at least 80% compliance and at least 80% follow-up at each wave, and evaluate the effect size associated with receiving standard care vs. standard care + PPCC in order to understand the promise of and appropriate power required for a larger clinical trial.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • first or second trimester of pregnancy
  • age 18 or older
  • self-reported tobacco use in the past 90 days or nicotine-dependence in the past year

排除标准

  • intend to terminate their pregnancy
  • intend to move out of the city within the next 12 months
  • are unable to provide informed consent and participate in English

研究组 & 干预措施

Standard care

Active Comparator

Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)

干预措施: Standard care (Behavioral)

Standard care plus PPCC

Experimental

Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum

干预措施: Phone-based postpartum continuing care (Behavioral)

Standard care plus PPCC

Experimental

Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum

干预措施: Standard care (Behavioral)

结局指标

主要结局

Number of Tobacco Products Per Day

时间窗: 6 months postpartum

Self-reported number of tobacco products smoked per day

次要结局

  • Number of Tobacco Products Per Day(3 months postpartum)
  • Past 90-day Tobacco Use(6 months postpartum)
  • Times Mother Smoked While Breastfeeding(Baby's birth to 6 months postpartum)
  • Times Mother Smoked in the Room With Infant(Baby's birth to 6 months postpartum)
  • NicCheck Test Results for Cotinine Level From Infant Urine(6 months postpartum)

研究者

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

Victoria H. Coleman-Cowger

Principal Research Scientist

Battelle Memorial Institute

研究点 (4)

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