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临床试验/NCT00310115
NCT00310115已完成不适用

Smoking Relapse Prevention Among Postpartum Women

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 469 人开始时间: 2002年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
469
试验地点
1
主要终点
Number of Patients with Smoking Abstinence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • age 18 or older
  • former smoker who quit during pregnancy as assessed via self-report
  • smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
  • 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
  • can speak, read and write in English.
  • must have a functioning home or personal cell phone

排除标准

  • high-risk pregnancy or known negative birth outcome

结局指标

主要结局

Number of Patients with Smoking Abstinence

时间窗: 26 weeks

Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment

次要结局

  • Number of Cigarettes Smoked Daily(26 weeks following study treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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