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临床试验/NCT00381823
NCT00381823Unknown2 期

Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 1,750 人开始时间: 2001年7月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
1,750
试验地点
2
主要终点
Reduction of risk behaviors:

研究概览

简要总结

The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.

详细描述

This study recruited pregnant, English speaking women from the District of Columbia who were African American or Latina and had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence. Women were randomized to receive either an integrated intervention or usual prenatal care. Women randomized to the intervention arm received a cognitive behavioral intervention delivered during the prenatal period in four to eight sessions. Up to two postpartum booster sessions were provided. Sessions were delivered coincident with prenatal care visits. Careful attention was paid to individualizing counseling to provide an integrated approach to each participant's multiple risk factors. The outcomes of interest were primarily behavior change with regard to the risk factors and secondarily to improved birth outcomes, specifically birthweight and gestation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Educational Counseling Training
盲法
None

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

  • African American or Latina (by self report)
  • At least 18 years of age
  • English speaking
  • Pregnant less than or equal to 28 weeks gestation
  • Receiving prenatal care in the District of Columbia
  • Had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence

排除标准

  • Non-minority race (by self report)
  • Younger than 18 years of age
  • Non-English speaking
  • Not pregnant or pregnant greater than 28 weeks gestation
  • Receiving prenatal care outside the District of Columbia
  • Responded negatively to questions about risk factors
  • Suicidal ideation

结局指标

主要结局

Reduction of risk behaviors:

Active smoking

Environmental Tobacco Smoke Exposure

Depression

Intimate Partner Violence

次要结局

  • birth weight
  • gestational age

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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