N/A
N=299
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
Emotional Disturbances · Depression · Pregnancy Late · Post-Partum Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03416010 ↗Enrolled (actual)
299
Serious AEs
1.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 — 59.044; 59.349; 64.972; 64.234 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COPE-P (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 |
59.044; 59.349; 64.972; 64.234; 63.683; 64.614 | <0.001 sig |
| PRIMARY Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 |
8.647; 9.018; 5.500; 5.447; 3.358; 4.114 | <0.001 sig |
| PRIMARY Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 |
49.506; 50.669; 56.194; 56.783; 53.677; 57.267 | <0.001 sig |
| PRIMARY Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 |
13.042; 12.855; 7.000; 7.776; 6.119; 6.545 | <0.001 sig |
| PRIMARY Change Self-reported Stress at Timepoint 0 to Timepoint 3 |
21.857; 21.971; 15.278; 15.596; 12.448; 13.420 | <0.001 sig |
| SECONDARY Birth Weight |
3139.9; 3310.1 | — |
| SECONDARY Breastfeeding Initiation |
64; 83 | — |
| SECONDARY Breastfeeding Duration |
18; 34 | — |
| SECONDARY Mode of Delivery |
52; 52; 0; 4; 17; 29 | — |
| SECONDARY Nutritional Intake |
3.955; 4.070; 4.264; 4.298; 4.075; 4.200 | — |
| SECONDARY Level of Exercise |
— | — |
| SECONDARY Gestational Age at Birth |
39.0; 38.8 | — |
| SECONDARY Weight |
174.3; 171.0 | — |
| SECONDARY Participant Body Mass Index (BMI) |
29.4; 29.2; 33.1; 31.8; 31.2; 29.7 | — |
| SECONDARY Participant Height |
63.9; 63.9 | — |
| SECONDARY Group Prenatal Care Acceptability |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Program Evaluation: Delivery Method |
9; 6; 3; 2; 9; 17 | — |
| SECONDARY COPE-P Acceptability |
94.05 | — |
| SECONDARY Program Evaluation |
31; 30; 0; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03416010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.