Breastfeeding Education and Support Trial for Obese Women... | NCT01338727

Studies
Breastfeeding Education and Support Trial for Obese Women (BESTOW)

NCT01338727

Sponsor

University of Connecticut

Status

Completed

Last Update Posted

Apr 19, 2011Estimated

Enrollment

206Actual

Phase

Not Applicable

Conditions

Exclusive Breastfeeding
Breastfeeding Initiation

Interventions

Breastfeeding Peer Counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DF05-015	Other Grant/Funding Number	The Donaghue Foundation

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Apr 6, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breastfeeding Peer Counseling	Experimental		Behavioral: Breastfeeding Peer Counseling
Standard Care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breastfeeding Peer Counseling	Behavioral	3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.	Breastfeeding Peer Counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exclusive Breastfeeding Rate		3 months postpartum

Secondary Outcomes

Measure	Description	Time Frame
Breastfeeding Rate		3 months postpartum
Breastfeeding Initiation Rate		For the duration of the hospital stay, average equals 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rafael Pérez-Escamilla, PhD	University of Connecticut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Connecticut		Storrs	Connecticut	06269-4017	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23209111	Derived	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.

ID	Term
D005247	Feeding Behavior
D001519	Behavior