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Influence of Bottle-Type on Infant Feeding Behaviors (OBS)

Primary Purpose

Conventional Clear Bottle, Opaque Weighted Bottle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bottle Type
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Conventional Clear Bottle focused on measuring infant, intake, satiation, mother, feeding practices, bottle feeding, formula feeding, maternal responsiveness, infant cues

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Preterm birth
  • Medical conditions that interfere with feeding

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clear versus Opaque Bottle

Arm Description

This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants.

Outcomes

Primary Outcome Measures

Infant intake within a feeding (mL)
assessed by weighing the bottle before and after a feeding
Maternal responsiveness to infant cues during a feeding
assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale

Secondary Outcome Measures

Maternal perception/acceptance of the bottles during a feeding

Full Information

First Posted
March 26, 2014
Last Updated
October 28, 2015
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT02111694
Brief Title
Influence of Bottle-Type on Infant Feeding Behaviors
Acronym
OBS
Official Title
Influence of Bottle-Type on Infant Feeding Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the proposed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conventional Clear Bottle, Opaque Weighted Bottle
Keywords
infant, intake, satiation, mother, feeding practices, bottle feeding, formula feeding, maternal responsiveness, infant cues

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clear versus Opaque Bottle
Arm Type
Experimental
Arm Description
This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants.
Intervention Type
Behavioral
Intervention Name(s)
Bottle Type
Intervention Description
Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding
Primary Outcome Measure Information:
Title
Infant intake within a feeding (mL)
Description
assessed by weighing the bottle before and after a feeding
Time Frame
3-hour period
Title
Maternal responsiveness to infant cues during a feeding
Description
assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale
Time Frame
3-hour period
Secondary Outcome Measure Information:
Title
Maternal perception/acceptance of the bottles during a feeding
Time Frame
3-hour period

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mothers must be 18 years or older Infants must be between 0- and 6-months of age Infants must be prior to the introduction of solid foods Exclusion Criteria: Preterm birth Medical conditions that interfere with feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison K Ventura, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25445988
Citation
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.
Results Reference
result
PubMed Identifier
25953601
Citation
Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.
Results Reference
derived

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Influence of Bottle-Type on Infant Feeding Behaviors

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