Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Exclusive Breastfeeding Clinical Trial

— BESTOW  

Official title:

Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338727
• Other study ID #: H06-009
• Secondary ID: DF05-015
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 18, 2011
• Start date: September 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breastfeeding Initiation
• Exclusive Breastfeeding

Intervention

Behavioral:
• Breastfeeding Peer Counseling
3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive Breastfeeding Rate		3 months postpartum	No
Secondary	Breastfeeding Rate		3 months postpartum	No
Secondary	Breastfeeding Initiation Rate		For the duration of the hospital stay, average equals 3 days	No