NCT01043978

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Apr 2010

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

January 5, 2010

Last Update Submit

August 23, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Intake

    per feed

Secondary Outcomes (1)

  • Growth

    4 months

Study Arms (2)

Novel nipple

EXPERIMENTAL
Behavioral: Use of baby bottle nipple

Coventional nipple

ACTIVE COMPARATOR
Behavioral: Use of baby bottle nipple

Interventions

Use of baby bottle nippleBEHAVIORAL

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

Coventional nippleNovel nipple

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathryn G Dewey, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 7, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2011

Study Completion

August 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

US(1)