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