Healthy Outcomes of Pregnancy Education
Primary Purpose
Environmental Tobacco Smoke Exposure, Depression, Partner Abuse
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Environmental Tobacco Smoke Exposure focused on measuring Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke
Eligibility 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
Sites / Locations
- Howard University
Outcomes
Primary Outcome Measures
Reduction of risk behaviors:
Active smoking
Environmental Tobacco Smoke Exposure
Depression
Intimate Partner Violence
Secondary Outcome Measures
birth weight
gestational age
Full Information
NCT ID
NCT00381823
First Posted
September 26, 2006
Last Updated
September 28, 2006
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's National Research Institute, Georgetown University, George Washington University, Howard University, RTI International
1. Study Identification
Unique Protocol Identification Number
NCT00381823
Brief Title
Healthy Outcomes of Pregnancy Education
Official Title
Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's National Research Institute, Georgetown University, George Washington University, Howard University, RTI International
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Tobacco Smoke Exposure, Depression, Partner Abuse, Tobacco Smoking
Keywords
Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
Reduction of risk behaviors:
Title
Active smoking
Title
Environmental Tobacco Smoke Exposure
Title
Depression
Title
Intimate Partner Violence
Secondary Outcome Measure Information:
Title
birth weight
Title
gestational age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Kiely, DrPH
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Study Director
Facility Information:
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32608505
Citation
Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
Results Reference
derived
PubMed Identifier
27094910
Citation
Backonja U, Robledo CA, Wallace ME, Flores KF, Kiely M. Reproductive Health Knowledge among African American Women Enrolled in a Clinic-Based Randomized Controlled Trial to Reduce Psychosocial and Behavioral Risk: Project DC-HOPE. Womens Health Issues. 2016 Jul-Aug;26(4):442-51. doi: 10.1016/j.whi.2016.03.005. Epub 2016 Apr 16.
Results Reference
derived
PubMed Identifier
21785892
Citation
Kiely M, El-Mohandes AA, Gantz MG, Chowdhury D, Thornberry JS, El-Khorazaty MN. Understanding the association of biomedical, psychosocial and behavioral risks with adverse pregnancy outcomes among African-Americans in Washington, DC. Matern Child Health J. 2011 Dec;15 Suppl 1(Suppl 1):S85-95. doi: 10.1007/s10995-011-0856-z.
Results Reference
derived
PubMed Identifier
21656058
Citation
El-Mohandes AA, El-Khorazaty MN, Kiely M, Gantz MG. Smoking cessation and relapse among pregnant African-American smokers in Washington, DC. Matern Child Health J. 2011 Dec;15 Suppl 1(Suppl 1):S96-105. doi: 10.1007/s10995-011-0825-6.
Results Reference
derived
PubMed Identifier
21565525
Citation
Molina KM, Kiely M. Understanding depressive symptoms among high-risk, pregnant, African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):293-303. doi: 10.1016/j.whi.2011.01.008. Epub 2011 May 12.
Results Reference
derived
PubMed Identifier
20211945
Citation
El-Mohandes AA, Kiely M, Blake SM, Gantz MG, El-Khorazaty MN. An intervention to reduce environmental tobacco smoke exposure improves pregnancy outcomes. Pediatrics. 2010 Apr;125(4):721-8. doi: 10.1542/peds.2009-1809. Epub 2010 Mar 8.
Results Reference
derived
PubMed Identifier
20093899
Citation
Kiely M, El-Mohandes AAE, El-Khorazaty MN, Gantz MG. An integrated intervention to reduce intimate partner violence in pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):273-283. doi: 10.1097/AOG.0b013e3181cbd482. Erratum In: Obstet Gynecol. 2011 May;117(5):1232. Blake, Susan M [added].
Results Reference
derived
PubMed Identifier
19786427
Citation
El-Mohandes AA, Kiely M, Gantz MG, Blake SM, El-Khorazaty MN. Prediction of birth weight by cotinine levels during pregnancy in a population of black smokers. Pediatrics. 2009 Oct;124(4):e671-80. doi: 10.1542/peds.2008-3784. Epub 2009 Sep 28.
Results Reference
derived
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Healthy Outcomes of Pregnancy Education
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