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Prevention of Overfeeding During Infancy

NCT ID: NCT01043978

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Novel nipple

Group Type EXPERIMENTAL

Use of baby bottle nipple

Intervention Type BEHAVIORAL

Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle

Coventional nipple

Group Type ACTIVE_COMPARATOR

Use of baby bottle nipple

Intervention Type BEHAVIORAL

Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn G Dewey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200715679

Identifier Type: -

Identifier Source: org_study_id