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Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
NCT03416010 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL COPE-P
Study Locations (3)
Ohio
- OSU Total Health and Wellness — Columbus
- OSUWMC OB/GYN Clinic — Columbus
New York
- Jacobi Medical Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2023-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03416010
The ClinicalTrials.gov registry entry for NCT03416010 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention — of which COPE-P is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03416010 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Ohio, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03416010 about?
NCT03416010 is a clinical study titled "Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women". 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 (CB...
What is the current status of trial NCT03416010?
This trial is currently completed. It is a NA study. The enrollment target is 299 participants. The study started on 2018-03-05. Estimated completion is 2023-04-20.
What conditions does trial NCT03416010 study?
This clinical trial studies the following conditions: Depression, Anxiety, Nutritional Deficiency, Emotional Disturbances, Pregnancy Late. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03416010?
The interventions under investigation include: COPE-P (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03416010?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03416010 being conducted?
This trial has 3 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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