Influence of Bottle-Type of Infant Feeding Behavior
OBS-II
1 other identifier
interventional
48
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 9, 2018
January 1, 2018
2.3 years
August 5, 2015
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
EXPERIMENTALThis 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.
Interventions
This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.
This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.
Eligibility Criteria
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
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison K Ventura, PhD
Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- 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