BreastfeedingBINGONCT00619632
Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
A study testing Lactation Consultant, Provider Prompt and LC+ Provider Prompt in people with Breastfeeding and Breastfeeding, Exclusive, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive
- What is being tested?
- Lactation Consultant, Provider Prompt and LC+ Provider Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled/plan to remain in care at the site throughout their pregnancy
- 1st or 2nd trimester (randomization will include trimester as a blocking factor)
- Aged 18 or older
- Can provide a reliable phone number and at least 2 alternative contacts
- Are carrying a singleton pregnancy
- Can communicate in English or Spanish
Who cannot join
- High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
- Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
- On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
- Enrolled in site's Group Pre-natal Care (app. 60 women/year)
- Previously enrolled in MILK study
- Craniofacial or neurological conditions that prevent an infant from BF (post-partum exclusion)
- Reported use of street drugs (responds to reviewer comment of how to control for this)
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Family Care Center
The Bronx, New York, 10461
About this study
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.
Read more
Primary Outcomes (Hypotheses): Breastfeeding
- Breastfeeding Intensity at 1,3, and 6 Months
- Exclusive Breastfeeding at 1,3, and 6 Months Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses
- To describe participant and provider (LC and PNC) experience of the interventions.
Read the detailed description
Primary Outcomes (Hypotheses): Breastfeeding
- Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences in breastfeeding intensity among the 4 treatment groups. We expect that intensity will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
- Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences in the rate of exclusive breastfeeding among the 4 treatment groups. We expect that rates of exclusive breastfeeding will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively. Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses (i.e., otitis media, gastrointestinal, and respiratory infections) by treatment group.
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses by intensity of breastfeeding regardless of group assignment.
- To describe participant and provider (LC and PNC) experience of the interventions.
BINGO is the first RCT in the US of routine provider, primary-care based interventions to increase breastfeeding (BF). Government task forces in the US3 and Canada specifically call for such trials, as well as trials to assess independent effects of combined interventions. BINGO is the first trial to apply strategies derived from the current National Breastfeeding Awareness Campaign (NBAC). BINGO will employ the NBAC message-- that exclusive BF for 6 months reduces infant ear infections, diarrhea, respiratory illness, and perhaps childhood obesity. We expect this message will yield greater BF intensity, and thus progress toward pending Healthy People 2010 goals for exclusive BF.
BINGO uses evidence-based strategies in practice, consistent with the NIH roadmap. Its interventions are logistically and economically sustainable in clinical practice. They support women pre- and post-natally, across multiple care settings (clinic, hospital, home). Both Certified Nurse Midwives and Ob/Gyns, deliver the PNC intervention, thus increasing generalizability. BINGO now has the enthusiastic support of perinatal nursing, physician, and lactation specialist groups. This support, at the outset, provides the foundation for effective BINGO interventions to be translated into practice.
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Being tested
- Lactation Consultant, Provider Prompt, LC+ Provider Prompt
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactation ConsultantBehavioural
Lactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum.
Provider PromptBehavioural
Prompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise
LC+ Provider PromptBehavioural
Participants in this group receive both the LC and Provider Prompt interventions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LC- Primary-care based lactation consultant meeting women pre- and post-natally. Receives: Behavioral: Lactation Consultant |
| 2 | Experimental | Provider Prompt Receives: Behavioral: Provider Prompt |
| 3 | Experimental | LC+Provider Prompt Receives: Behavioral: LC+ Provider Prompt |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration and intensity
Measured: Assessed at 1,3, and 6 months
Secondary outcomes (2)
Infant health visits
Measured: 12 months
Patient and provider experiences of the interventions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Karen Bonuck, Albert Einstein College of Medicine
- Investigators
- Karen A. Bonuck, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619632
- Sponsor's protocol ID
- 06-08-364
- Other IDs
- NIH R01 HD04976301A2, Montefiore IRB= 06-08-364
- Acronym
- BINGO
- Status last verified
- Jan 2015
- First submitted
- 4 Feb 2008
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.
PubMed 24354834Andaya E, Bonuck K, Barnett J, Lischewski-Goel J. Perceptions of primary care-based breastfeeding promotion interventions: qualitative analysis of randomized controlled trial participant interviews. Breastfeed Med. 2012 Dec;7(6):417-22. doi: 10.1089/bfm.2011.0151. Epub 2012 May 23.
PubMed 22621223
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
- ClinicalTrials.gov ID
- NCT00619632
- Acronym / sponsor ID
- BINGO / 06-08-364
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Montefiore Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Breastfeeding Intensity at 1,3, and 6 Months
- Exclusive Breastfeeding at 1,3, and 6 Months Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses
- To describe participant and provider (LC and PNC) experience of the interventions.
Detailed description
Primary Outcomes (Hypotheses): Breastfeeding
- Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences in breastfeeding intensity among the 4 treatment groups. We expect that intensity will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
- Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences in the rate of exclusive breastfeeding among the 4 treatment groups. We expect that rates of exclusive breastfeeding will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively. Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses (i.e., otitis media, gastrointestinal, and respiratory infections) by treatment group.
- To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses by intensity of breastfeeding regardless of group assignment.
- To describe participant and provider (LC and PNC) experience of the interventions.
BINGO is the first RCT in the US of routine provider, primary-care based interventions to increase breastfeeding (BF). Government task forces in the US3 and Canada specifically call for such trials, as well as trials to assess independent effects of combined interventions. BINGO is the first trial to apply strategies derived from the current National Breastfeeding Awareness Campaign (NBAC). BINGO will employ the NBAC message-- that exclusive BF for 6 months reduces infant ear infections, diarrhea, respiratory illness, and perhaps childhood obesity. We expect this message will yield greater BF intensity, and thus progress toward pending Healthy People 2010 goals for exclusive BF.
BINGO uses evidence-based strategies in practice, consistent with the NIH roadmap. Its interventions are logistically and economically sustainable in clinical practice. They support women pre- and post-natally, across multiple care settings (clinic, hospital, home). Both Certified Nurse Midwives and Ob/Gyns, deliver the PNC intervention, thus increasing generalizability. BINGO now has the enthusiastic support of perinatal nursing, physician, and lactation specialist groups. This support, at the outset, provides the foundation for effective BINGO interventions to be translated into practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lactation ConsultantLC- Primary-care based lactation consultant meeting women pre- and post-natally. |
| 2 | Experimental | Behavioral: Provider PromptProvider Prompt |
| 3 | Experimental | Behavioral: LC+ Provider PromptLC+Provider Prompt |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled/plan to remain in care at the site throughout their pregnancy
- 1st or 2nd trimester (randomization will include trimester as a blocking factor)
- Aged 18 or older
- Can provide a reliable phone number and at least 2 alternative contacts
- Are carrying a singleton pregnancy
Key exclusion criteria (7 listed)
- High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
- Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
- On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
- Enrolled in site's Group Pre-natal Care (app. 60 women/year)
- Previously enrolled in MILK study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactation ConsultantLactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum. | Behavioural | 1 |
| Provider PromptPrompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise | Behavioural | 2 |
| LC+ Provider PromptParticipants in this group receive both the LC and Provider Prompt interventions. | Behavioural | 3 |
Primary outcome
Breastfeeding duration and intensity
Time frame: Assessed at 1,3, and 6 months
2 secondary outcomes
Infant health visits
Time frame: 12 months
Patient and provider experiences of the interventions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Derived from this study: PubMed 24354834Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.
- Derived from this study: PubMed 22621223Andaya E, Bonuck K, Barnett J, Lischewski-Goel J. Perceptions of primary care-based breastfeeding promotion interventions: qualitative analysis of randomized controlled trial participant interviews. Breastfeed Med. 2012 Dec;7(6):417-22. doi: 10.1089/bfm.2011.0151. Epub 2012 May 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen A. Bonuck, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactation Consultant, Provider Prompt and LC+ Provider Prompt in people with Breastfeeding and Breastfeeding, Exclusive, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding duration and intensity (time frame: Assessed at 1,3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00619632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.