Trial record 2 of 282 for:    lactation AND (woman OR women OR female)

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
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 April 17, 2014