NCT02519179

Brief Summary

The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

August 5, 2015

Last Update Submit

October 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Infant intake

    Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.

    3-hour period

  • Maternal responsiveness

    Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.

    3-hour period

Secondary Outcomes (1)

  • Maternal acceptance/perception of intervention

    3-hour period

Study Arms (1)

Conventional vs. Opaque, Weighted Bottle

EXPERIMENTAL

This is a within-subject experiment; mothers will be asked to feed their infants from a clear, conventional bottle during one visit and an opaque, weighted bottle during the other visit. Order of conditions will be counterbalanced.

Behavioral: Opaque, weighted bottleBehavioral: Clear, conventional bottle

Interventions

This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.

Conventional vs. Opaque, Weighted Bottle

This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.

Conventional vs. Opaque, Weighted Bottle

Eligibility Criteria

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

You may qualify if:

  • Mothers must be 18 years or older
  • Infants must be between 0-6 months of age
  • Infants must be prior to the introduction of solid foods

You may not qualify if:

  • Preterm birth
  • Medical conditions that interfere with feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93401, United States

Location

Related Publications (1)

  • Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.

    PMID: 25445988BACKGROUND

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Alison K Ventura, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a within-subject study; mothers are observed during both feeding conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 10, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

August 1, 2018

Last Updated

October 9, 2018

Record last verified: 2018-01

Locations