CompletedNot Applicable

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

United States299 participantsStarted 2018-03-05

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Change Self-reported Stress at Timepoint 0 to Timepoint 3

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Trial details

NCT IDNCT03416010

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

Results submitted2024-11-22

View on ClinicalTrials.gov More Emotional Disturbances trials