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Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

2016年9月21日 更新者：M.D. Anderson Cancer Center

Smoking Relapse Prevention Among Postpartum Women

RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.

PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
  • Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
  • Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.

  • Arm I (usual care [UC]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
  • Arm II (motivational relapse prevention [MRP]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
  • Arm III (enhanced MRP [MRP+]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.

Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.

Participants are followed at 8 and 26 weeks postpartum.

PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.

研究类型

观察性的

注册 (实际的)

469

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Texas
      • Houston、Texas、美国、77030-4009
        • University of Texas MD Anderson Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Women, 18 years of age or older, who quit smoking while pregnant.

描述

Inclusion Criteria:

  1. age 18 or older
  2. former smoker who quit during pregnancy as assessed via self-report
  3. smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
  4. gestational age < 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
  5. can speak, read and write in English.
  6. must have a functioning home or personal cell phone

Exclusion Criteria:

1) high-risk pregnancy or known negative birth outcome

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Smoking Prevention Usual Care
Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.
行为的：Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
MRP
Arm II (motivational relapse prevention [MRP]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 & 36 weeks gestation then at 2, 4, 7, & 16 weeks postpartum.
行为的：Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
行为的：Counseling Intervention
6 x 30 minute counseling sessions over the telephone
行为的：Counseling Intervention
2 in-person counseling sessions
Enhanced MRP +
Arm III (enhanced MRP [MRP+]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation & 8 weeks postpartum.
行为的：Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
行为的：Counseling Intervention
6 x 30 minute counseling sessions over the telephone
行为的：Counseling Intervention
2 in-person counseling sessions

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Patients with Smoking Abstinence
大体时间：26 weeks
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
26 weeks

次要结果测量

结果测量
措施说明
大体时间
Number of Cigarettes Smoked Daily
大体时间：26 weeks following study treatment
Cigarettes smoked per day at 26 weeks following study treatment
26 weeks following study treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

M.D. Anderson Cancer Center

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：David Wetter, PhD, BS, BA、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年4月1日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2006年3月29日

首先提交符合 QC 标准的

2006年3月29日

首次发布 (估计)

2006年4月3日

研究记录更新

最后更新发布 (估计)

2016年9月23日

上次提交的符合 QC 标准的更新

2016年9月21日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BS01-178
  • P30CA016672 (美国 NIH 拨款/合同)
  • R01CA089350 (美国 NIH 拨款/合同)
  • MDA-BS01-178 (其他标识符：UT MD Anderson Cancer Center)
  • CDR0000466327 (注册表标识符：NCI PDQ)
  • NCI-2010-01136 (注册表标识符：NCI CTRP)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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