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Prevention of Overfeeding During Infancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043978
First Posted: January 7, 2010
Last Update Posted: August 24, 2012
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.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.

Condition Intervention Phase
Obesity Behavioral: Use of baby bottle nipple Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Overfeeding During Infancy

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Intake [ Time Frame: per feed ]

Secondary Outcome Measures:
  • Growth [ Time Frame: 4 months ]

Enrollment: 231
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novel nipple Behavioral: Use of baby bottle nipple
Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle
Active Comparator: Coventional nipple Behavioral: Use of baby bottle nipple
Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infant born at > 37 weeks gestation
  • Infant weighed >2500 g at birth
  • Infant is apparently healthy
  • Mother speaks English
  • Mother is 18 years of age or older
  • Mother/infant pair lives within a 10-mile radius around the UC Davis Medical Center in Sacramento, CA
  • Mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.
  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): NCT01043978


Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01043978     History of Changes
Other Study ID Numbers: 200715679
First Submitted: January 5, 2010
First Posted: January 7, 2010
Last Update Posted: August 24, 2012
Last Verified: August 2012