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Healthy Outcomes of Pregnancy Education

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00381823
Enrollment
1750
Registered
2006-09-28
Start date
2001-07-31
Completion date
2004-08-31
Last updated
2006-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

Sponsors

Children's National Research Institute
CollaboratorOTHER
Georgetown University
CollaboratorOTHER
George Washington University
CollaboratorOTHER
Howard University
CollaboratorOTHER
RTI International
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Active smoking
Depression
Intimate Partner Violence
Reduction of risk behaviors:
Environmental Tobacco Smoke Exposure

Secondary

MeasureTime frame
gestational age
birth weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026