Clincosm LogoSign in Get a demo

Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Sponsor
University of Connecticut (Other)
Overall Status
Completed
CT.gov ID
NCT01338727
Collaborator
(none)
206
Enrollment
1
Location
2
Arms
42
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

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 Phase
  • Behavioral: Breastfeeding Peer Counseling
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2006
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

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 Names:
  • BESTOW

    		•
    No Intervention: Standard Care

    Outcome Measures

    Primary Outcome Measures

    1. Exclusive Breastfeeding Rate [3 months postpartum]

    Secondary Outcome Measures

    1. Breastfeeding Rate [3 months postpartum]

    2. Breastfeeding Initiation Rate [For the duration of the hospital stay, average equals 3 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01338727
    Other Study ID Numbers:
    • H06-009
    • DF05-015
    First Posted:
    Apr 19, 2011
    Last Update Posted:
    Apr 19, 2011
    Last Verified:
    Apr 1, 2011

    Study Results

    No Results Posted as of Apr 19, 2011