Prevention of Overfeeding During Infancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01043978
First received: January 5, 2010
Last updated: August 23, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Overfeeding During Infancy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Intake [ Time Frame: per feed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01043978     History of Changes
Other Study ID Numbers: 200715679
Study First Received: January 5, 2010
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014