Healthy Outcomes of Pregnancy Education

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Environmental Tobacco Smoke Exposure, Depression, Partner Abuse, Tobacco Smoking

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of risk behaviors: |  |  | 
| Active smoking |  |  | 
| Environmental Tobacco Smoke Exposure |  |  | 
| Depression |  |  | 
| Intimate Partner Violence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight |  |  | 
| gestational age |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke