Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    500
  • sponsor
    Ohio State University
Updated on 8 April 2021
prenatal
emotional distress

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 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.

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 determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. Developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Details
Condition Endogenous depression, Depression, Malnutrition, Postpartum depression, Alexithymia, ANXIETY NEUROSIS, Anxiety, Malnutrition, Depression (Major/Severe), Anxiety Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Post-Partum Depression, Anxiety Symptoms, Pregnancy Late, Late Pregnancy, Anxiety Disorders, depressive disorder, emotional disturbances, deficiency, malnourished, undernutrition, nutritional deficiency, nutritional deficiencies, undernourished, poor nutrition, deficit, anxiety disorder, depressed mood, miserable, depressive disorders, anxious
Treatment COPE-P
Clinical Study IdentifierNCT03416010
SponsorOhio State University
Last Modified on8 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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