Breastfeeding Education and Support Trial for Obese Women (BESTOW)

NCT ID: NCT01338727

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Exclusive Breastfeeding Breastfeeding Initiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Breastfeeding Peer Counseling

Group Type EXPERIMENTAL

Breastfeeding Peer Counseling

Intervention Type BEHAVIORAL

3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastfeeding Peer Counseling

3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.

Intervention Type BEHAVIORAL

Other Intervention Names

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BESTOW

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* HIV positive or having other conditions which interfere with exclusive breastfeeding
* Infant admitted to the Neonatal Intensive Care Unit
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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University of Connecticut

Principal Investigators

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Rafael Pérez-Escamilla, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23209111 (View on PubMed)

Other Identifiers

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DF05-015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H06-009

Identifier Type: -

Identifier Source: org_study_id

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