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Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
NCT00619632 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in low-income multiethnic women, with stratification for maternal country of birth. The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions will be tested, compared to a Control standard of care. The intervention and design build upon our prior trial of an LC intervention alone. PNCs- certified nurse midwives and ob/gyns-- will use a brief, electronically prompted protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will collect infant feeding, and health visit data outside the medical center. Medical center visit data will be obtained from MIS data. Primary Outcomes (Hypotheses): Breastfeeding 1. Breastfeeding Intensity at 1,3, and 6 Months 2. Exclusive Breastfeeding at 1,3, and 6 Months Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience 3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses 4. To describe participant and provider (LC and PNC) experience of the interventions.
Conditions Studied
Interventions
- BEHAVIORAL Provider Prompt
- BEHAVIORAL Lactation Consultant
- BEHAVIORAL LC+ Provider Prompt
Study Locations (1)
New York
- Comprehensive Family Care Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619632
The ClinicalTrials.gov registry entry for NCT00619632 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 666 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Breastfeeding appearing as the primary indexed condition, and to 3 interventions — of which Provider Prompt 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: NCT00619632 reports 1 study location spanning 1 distinct geographic area — top geographies include 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 NCT00619632 about?
NCT00619632 is a clinical study titled "Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT". This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in low-income multiethnic women, with stratification for maternal country of birth. The Best Infant Nutri...
What is the current status of trial NCT00619632?
This trial is currently completed. It is a NA study. The enrollment target is 666 participants. The study started on 2008-02. Estimated completion is 2013-02.
What conditions does trial NCT00619632 study?
This clinical trial studies the following conditions: Breastfeeding, Breastfeeding, Exclusive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00619632?
The interventions under investigation include: Provider Prompt (BEHAVIORAL), Lactation Consultant (BEHAVIORAL), LC+ Provider Prompt (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00619632?
This trial is sponsored by Albert Einstein College of Medicine, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00619632 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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