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Infant Feeding Study.09-68

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233427
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.

Condition or disease
Describe the Infant Feeding Attitudes Intentions of a Sample of Expectant First-time Mothers Estimate the Prevalence of Early Lactation Difficulties

Detailed Description:
The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.

Study Design

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.
Study Start Date : June 2009
Primary Completion Date : November 2010
Study Completion Date : October 2011
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Early lactation difficulties [ Time Frame: 1 year ]
    a)Estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding, b) examine the relationship between metabolic health and lactation difficulties


Secondary Outcome Measures :
  1. Infant feeding attitudes [ Time Frame: 1 year ]
    describe the prenatal infant feeding attitudes and intentions of a sample of expectant mothers from the same recruitment base as the future intervention trial


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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
breastfeeding moms
Criteria

Inclusion Criteria:

  • First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

  • 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
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): NCT01233427


Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Laurie A Nommsen-Rivers, PhD Children's Hospital Medical Center, Cincinnati
More Information

Publications:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01233427     History of Changes
Other Study ID Numbers: 09-68
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014