Healthy Outcomes of Pregnancy Education

September 28, 2006 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

1750

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Depression
Reduction of risk behaviors:
Active smoking
Environmental Tobacco Smoke Exposure
Intimate Partner Violence

Secondary Outcome Measures

Outcome Measure
birth weight
gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Georgetown University
George Washington University
Children's National Research Institute
RTI International
Howard University

Investigators

  • Study Director: Michele Kiely, DrPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2006

Last Update Submitted That Met QC Criteria

September 28, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE Study
  • 3U18HD030445 (U.S. NIH Grant/Contract)
  • 3U18HD030447 (U.S. NIH Grant/Contract)
  • 5U18HD031206 (U.S. NIH Grant/Contract)
  • 3U18HD031919 (U.S. NIH Grant/Contract)
  • 5U18HD036104 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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