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NCT00619632 · ClinicalTrials.gov registry record · NA
Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
A NA study of Breastfeeding and Breastfeeding, Exclusive, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 666
- Enrollment target
- 1
- Study location
NCT00619632 is a NA study of Breastfeeding and Breastfeeding, Exclusive that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 666 participants, roughly in line with the 694-participant average among 28 other Breastfeeding trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00619632, a NA study of Breastfeeding and Breastfeeding, Exclusive, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 666 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 694-participant average among 28 other Breastfeeding trials with a reported enrollment target. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
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.
NCT00619632 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
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.
What interventions are being tested in trial NCT00619632?
The interventions under investigation include: Provider Prompt (BEHAVIORAL), Lactation Consultant (BEHAVIORAL), LC+ Provider Prompt (BEHAVIORAL).
Who is sponsoring clinical trial NCT00619632?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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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