Status:
COMPLETED
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institutes of Health (NIH)
New York University
Conditions:
Emotional Disturbances
Depression
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized cont...
Detailed Description
A randomized controlled trial will test a cognitive behavioral skills building intervention (COPE-P) in Black and Hispanic women experiencing emotional distress in two sites (New York and Ohio) to det...
Eligibility Criteria
Inclusion
- Pregnant women between the ages of 18-40 years old
- Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
- Self-identified as either Black or Hispanic
- Able to read and speak English.
- The child participants born to the participants will have their record accessed for data collection.
Exclusion
- Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
- Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT03416010
Start Date
March 5 2018
End Date
April 20 2023
Last Update
March 18 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Jacobi Medical Center
The Bronx, New York, United States, 10461
2
OSU Total Health and Wellness
Columbus, Ohio, United States, 43210
3
OSUWMC OB/GYN Clinic
Columbus, Ohio, United States, 43210