Healthy Outcomes of Pregnancy Education

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Children's Research Institute
Georgetown University
George Washington University
Howard University
RTI International
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00381823
First received: September 26, 2006
Last updated: September 28, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Environmental Tobacco Smoke Exposure
Depression
Partner Abuse
Tobacco Smoking
Behavioral: Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Secondary Outcome Measures:
  • birth weight
  • gestational age

Estimated Enrollment: 1750
Study Start Date: July 2001
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381823

Locations
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20059
Sponsors and Collaborators
Children's Research Institute
Georgetown University
George Washington University
Howard University
RTI International
Investigators
Study Director: Michele Kiely, DrPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00381823     History of Changes
Other Study ID Numbers: HOPE Study, 3U18HD030445, 3U18HD030447, 5U18HD31206, 3U18HD031919, 5U18HD036104
Study First Received: September 26, 2006
Last Updated: September 28, 2006
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pregnant women
Intervention Studies
African Americans
Infant Mortality
Environmental Tobacco Smoke Pollution
Depression
Partner Abuse
Tobacco Smoke

Additional relevant MeSH terms:
Depression
Depressive Disorder
Smoking
Behavioral Symptoms
Mood Disorders
Mental Disorders
Food Habits
Habits

ClinicalTrials.gov processed this record on July 31, 2014