Healthy Outcomes of Pregnancy Education

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Childrens 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

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 II

MedlinePlus related topics: Depression Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)

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

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

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

Childrens 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

Study ID Numbers:	HOPE Study, 3U18HD030445, 3U18HD030447, 5U18HD31206, 3U18HD031919, 5U18HD036104
Study First Received:	September 26, 2006
Last Updated:	September 28, 2006
ClinicalTrials.gov Identifier:	NCT00381823
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

Study placed in the following topic categories:

Smoking
Depression
Mental Disorders
Mood Disorders

Healthy
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 16, 2009