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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02111694
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Drexel University

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.

Condition or disease Intervention/treatment Phase
Conventional Clear Bottle Opaque Weighted Bottle Behavioral: Bottle Type Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influence of Bottle-Type on Infant Feeding Behaviors
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Clear versus Opaque Bottle
This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants.
Behavioral: Bottle Type
Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding

Primary Outcome Measures :
  1. Infant intake within a feeding (mL) [ Time Frame: 3-hour period ]
    assessed by weighing the bottle before and after a feeding

  2. Maternal responsiveness to infant cues during a feeding [ Time Frame: 3-hour period ]
    assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale

Secondary Outcome Measures :
  1. Maternal perception/acceptance of the bottles during a feeding [ Time Frame: 3-hour period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02111694

United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
Principal Investigator: Alison K Ventura, PhD Drexel University

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Drexel University Identifier: NCT02111694     History of Changes
Other Study ID Numbers: OBS-1303001967
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by Drexel University:
feeding practices
bottle feeding
formula feeding
maternal responsiveness
infant cues