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 range18 Years – 40 Years

SexFEMALE

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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.

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