Exclusive BreastfeedingBESTOWNCT01338727
Breastfeeding Education and Support Trial for Obese Women (BESTOW)
A study testing Breastfeeding Peer Counseling in people with Exclusive Breastfeeding and Breastfeeding Initiation, run by University of Connecticut at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Exclusive Breastfeeding, Breastfeeding Initiation
- What is being tested?
- Breastfeeding Peer Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese (prepregnant BMI 27.0 or greater)
- pregnant women delivering at Hartford Hospital
- no more than 34 weeks gestation
- considering breastfeeding this child
- low income (<185% Federal poverty level)
- planning to remain in the greater Hartford area for 6 months postpartum
- must have access to a telephone for follow-up interviews
- delivery of a healthy, term, singleton
Who cannot join
- HIV positive or having other conditions which interfere with exclusive breastfeeding
- Infant admitted to the Neonatal Intensive Care Unit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269-4017
About this study
The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.
- Conditions
- Exclusive Breastfeeding, Breastfeeding Initiation
- Being tested
- Breastfeeding Peer Counseling
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Peer CounselingBehavioural
Also called BESTOW
3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Peer Counseling | Experimental | Not described Receives: Behavioral: Breastfeeding Peer Counseling |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Breastfeeding Rate
Measured: 3 months postpartum
Secondary outcomes (2)
Breastfeeding Rate
Measured: 3 months postpartum
Breastfeeding Initiation Rate
Measured: For the duration of the hospital stay, average equals 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startSep 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exclusive 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Investigators
- Rafael Pérez-Escamilla, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338727
- Sponsor's protocol ID
- H06-009
- Other IDs
- DF05-015
- Acronym
- BESTOW
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chapman DJ, Morel K, Bermudez-Millan A, Young S, Damio G, Perez-Escamilla R. Breastfeeding education and support trial for overweight and obese women: a randomized trial. Pediatrics. 2013 Jan;131(1):e162-70. doi: 10.1542/peds.2012-0688. Epub 2012 Dec 3.
PubMed 23209111
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Education and Support Trial for Obese Women (BESTOW)
- ClinicalTrials.gov ID
- NCT01338727
- Acronym / sponsor ID
- BESTOW / H06-009
- Conditions
- Exclusive Breastfeeding, Breastfeeding Initiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Apr 2011 (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.
The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Peer Counseling | Experimental | Behavioral: Breastfeeding Peer Counseling |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- obese (prepregnant BMI 27.0 or greater)
- pregnant women delivering at Hartford Hospital
- no more than 34 weeks gestation
- considering breastfeeding this child
- low income (<185% Federal poverty level)
Key exclusion criteria (2 listed)
- HIV positive or having other conditions which interfere with exclusive breastfeeding
- Infant admitted to the Neonatal Intensive Care Unit
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 |
|---|---|---|
| Breastfeeding Peer CounselingAlso: BESTOW3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits. | Behavioural | Breastfeeding Peer Counseling |
Primary outcome
Exclusive Breastfeeding Rate
Time frame: 3 months postpartum
2 secondary outcomes
Breastfeeding Rate
Time frame: 3 months postpartum
Breastfeeding Initiation Rate
Time frame: For the duration of the hospital stay, average equals 3 days
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 19 Apr 2011.
- Derived from this study: PubMed 23209111Chapman DJ, Morel K, Bermudez-Millan A, Young S, Damio G, Perez-Escamilla R. Breastfeeding education and support trial for overweight and obese women: a randomized trial. Pediatrics. 2013 Jan;131(1):e162-70. doi: 10.1542/peds.2012-0688. Epub 2012 Dec 3.
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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.
Rafael Pérez-Escamilla, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Peer Counseling in people with Exclusive Breastfeeding and Breastfeeding Initiation, run by University of Connecticut 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 8 inclusion and 2 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 19 Apr 2011. 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?
Exclusive Breastfeeding Rate (time frame: 3 months postpartum). 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 NCT01338727, which also lists 1 linked publication.
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 19 Apr 2011.