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Holistic Assessment of Tulsa Children's Health
NCT04158089 · View on ClinicalTrials.gov ↗
Study Summary
The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy using a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 women (ages 18 or older) who are 12-16 weeks pregnant. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Pre- and post-tests will be used to assess maternal-fetal bonding and smoking before and after the intervention to allow for examination of change across pregnancy. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)
Study Locations (1)
Oklahoma
- OU Women's Health and Specialty Clinic — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2023-07-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04158089
The ClinicalTrials.gov registry entry for NCT04158089 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 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 306 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Babies and Moms connected through Love, Openness, and Opportunity (BLOOM) 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: NCT04158089 reports 1 study location spanning 1 distinct geographic area — top geographies include Oklahoma. 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 NCT04158089 about?
NCT04158089 is a clinical study titled "Holistic Assessment of Tulsa Children's Health". The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in mater...
What is the current status of trial NCT04158089?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2021-12-20. Estimated completion is 2023-07-18.
What conditions does trial NCT04158089 study?
This clinical trial studies the following conditions: Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04158089?
The interventions under investigation include: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04158089?
This trial is sponsored by University of Oklahoma, which has 306 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04158089 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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