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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

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 10, 2015
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
  • Infant intake [ Time Frame: 3-hour period ]
    Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Bottle-Type of Infant Feeding Behavior
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Bottle Feeding
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Behavioral: Opaque, weighted bottle
  • Behavioral: Clear, conventional bottle
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2015)
50
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02519179
Other Study ID Numbers  ICMJE 00000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alison Ventura, California Polytechnic State University-San Luis Obispo
Study Sponsor  ICMJE California Polytechnic State University-San Luis Obispo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alison K Ventura, PhD Assistant Professor
PRS Account California Polytechnic State University-San Luis Obispo
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP