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

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ClinicalTrials.gov Identifier: NCT01338727
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Exclusive Breastfeeding Breastfeeding Initiation Behavioral: Breastfeeding Peer Counseling

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Breastfeeding Education and Support Trial for Obese Women (BESTOW)
Study Start Date : September 2006
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Exclusive Breastfeeding Rate [ Time Frame: 3 months postpartum ]

Secondary Outcome Measures :
  1. Breastfeeding Rate [ Time Frame: 3 months postpartum ]
  2. Breastfeeding Initiation Rate [ Time Frame: For the duration of the hospital stay, average equals 3 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: The Donaghue Foundation )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011