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

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ClinicalTrials.gov Identifier: NCT02111694
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : October 30, 2015
Sponsor:
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02111694


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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drexel University
ClinicalTrials.gov 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:
infant
intake
satiation
mother
feeding practices
bottle feeding
formula feeding
maternal responsiveness
infant cues