Healthy Outcomes of Pregnancy Education

Phase 2

• Conditions: Environmental Tobacco Smoke Exposure; Depression; Partner Abuse; Tobacco Smoking

• Registration Number: NCT00381823
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-07
• Study Completion: 2004-08
• Status Verified: 2006-09
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Last Update Submitted: 2006-09-28
• Last Update Posted: 2006-09-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of risk behaviors:
Active smoking
Environmental Tobacco Smoke Exposure
Depression
Intimate Partner Violence

Secondary Outcome Measures

Name	Time	Method
birth weight
gestational age

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States