Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

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


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.


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note