Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Completed · Not applicable

Conditions studied: Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression, Anxiety, Nutritional Deficiency

In brief

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 controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

Key facts

Study ID

NCT03416010

Run by

Ohio State University

People needed

299

Starts

2018-03-05

Expected to finish

2023-04-20

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States
• OSU Total Health and Wellness — Columbus, Ohio, United States
• OSUWMC OB/GYN Clinic — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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