NCT01338727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

3.5 years

First QC Date

April 6, 2011

Last Update Submit

April 18, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exclusive Breastfeeding Rate

    3 months postpartum

Secondary Outcomes (2)

  • Breastfeeding Rate

    3 months postpartum

  • Breastfeeding Initiation Rate

    For the duration of the hospital stay, average equals 3 days

Study Arms (2)

Breastfeeding Peer Counseling

EXPERIMENTAL
Behavioral: Breastfeeding Peer Counseling

Standard Care

NO INTERVENTION

Interventions

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

Also known as: BESTOW
Breastfeeding Peer Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • HIV positive or having other conditions which interfere with exclusive breastfeeding
  • Infant admitted to the Neonatal Intensive Care Unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269-4017, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Rafael Pérez-Escamilla, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 19, 2011

Study Start

September 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations