NCT02284152

Brief Summary

In the present study, we tested a novel approach to understanding infant bottle-feeding interactions: experimentally manipulating bottle-feeding conditions to better understand maternal and infant influences on overfeeding, as well as individual differences in risk for overfeeding. Specifically, we observed mother-infant dyads during a typical, "mother-led" feeding, during which mothers were given no instruction regarding how or how much to feed their infants (hereafter referred to as a "typical feeding" \[TF\]), as well as during an "infant-led" (IL) feeding, wherein we minimized the mothers' influence on the feeding and ensured the feed was in response to the infants' hunger and fullness cues. Using this within-subject, objective, and experimental approach, the present study aimed to: 1) directly measure the extent to which overfeeding occurs during bottle-feeding and 2) describe the characteristics of infants and mothers that overfeed during bottle-feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

November 3, 2014

Last Update Submit

November 3, 2014

Conditions

Keywords

bottle feedingfeeding behaviorinfantsmothersresponsive feedingmaternal feeding practicesmaternal feeding styles

Outcome Measures

Primary Outcomes (1)

  • Infant Intake

    Infant intake was assessed by weighing the bottle before and after the feeding

    3-hour period

Study Arms (1)

Typical versus Infant-Led feeding

EXPERIMENTAL

This is a within-subject study; all infants and mothers will be exposed to both conditions (typical feeding versus infant-led feeding conditions). Order of presentation will be counterbalanced across infant/mother dyads.

Behavioral: infant-led feeding

Interventions

mothers' feeding practices and infant intakes were compared between a typical feeding condition and an infant-led feeding condition, where the experimenter ensured the feeding was in response to infant hunger and fullness cues.

Typical versus Infant-Led feeding

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Formula-feeding
  • Prior to the introduction of solid foods
  • Infants 0 to 6 months of age
  • Mothers 18 to 40 years of age

You may not qualify if:

  • Exclusively breast-feeding
  • Preterm
  • Medical conditions that interfered with feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Ventura AK, Inamdar LB, Mennella JA. Consistency in infants' behavioural signalling of satiation during bottle-feeding. Pediatr Obes. 2015 Jun;10(3):180-7. doi: 10.1111/ijpo.250. Epub 2014 Jul 3.

    PMID: 24990443BACKGROUND

MeSH Terms

Conditions

Bottle FeedingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Alison K Ventura, PhD

    Cal Poly University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 5, 2014

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations