Breastfeeding Education and Support Trial for Obese Women (BESTOW)

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01338727
First received: April 6, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Exclusive Breastfeeding
Breastfeeding Initiation
Behavioral: Breastfeeding Peer Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Exclusive Breastfeeding Rate [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breastfeeding Rate [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
  • Breastfeeding Initiation Rate [ Time Frame: For the duration of the hospital stay, average equals 3 days ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: September 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breastfeeding Peer Counseling Behavioral: Breastfeeding Peer Counseling
3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.
Other Name: BESTOW
No Intervention: Standard Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338727

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269-4017
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Rafael Pérez-Escamilla, PhD University of Connecticut
  More Information

No publications provided by University of Connecticut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rafael Pérez-Escamilla, University of Connecticut
ClinicalTrials.gov Identifier: NCT01338727     History of Changes
Other Study ID Numbers: H06-009, DF05-015
Study First Received: April 6, 2011
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014