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Influence of Bottle-Type of Infant Feeding Behavior (OBS-II)

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.
 
ClinicalTrials.gov Identifier: NCT02519179
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Alison Ventura, California Polytechnic State University-San Luis Obispo

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.

Condition or disease Intervention/treatment Phase
Bottle Feeding Behavioral: Opaque, weighted bottle Behavioral: Clear, conventional bottle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a within-subject study; mothers are observed during both feeding conditions.
Masking: None (Open Label)
Primary Purpose: Basic Science
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Conventional vs. Opaque, Weighted Bottle
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 bottle
This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.

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




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

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


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



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
Criteria

Inclusion Criteria:

  • 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

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): NCT02519179


Locations
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United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93401
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
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Principal Investigator: Alison K Ventura, PhD Assistant Professor
Publications:
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Responsible Party: Alison Ventura, Assistant Professor, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT02519179    
Other Study ID Numbers: 00000
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: January 2018