Healthy Outcomes of Pregnancy Education

United States Department of Health and Human Services (HHS)

Status and phase: Unknown; Phase 2

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

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00381823

3U18HD030447 (U.S. NIH Grant/Contract)

5U18HD031206 (U.S. NIH Grant/Contract)

5U18HD036104 (U.S. NIH Grant/Contract)

HOPE Study

3U18HD031919 (U.S. NIH Grant/Contract)

3U18HD030445 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Educational/Counseling/Training

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)