Influence of Bottle-Type of Infant Feeding Behavior

Bottle Feeding Clinical Trial

— OBS-II  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519179
• Other study ID #: 00000
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: January 2018
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Bottle Feeding

Intervention

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

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant intake	Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.	3-hour period
Primary	Maternal responsiveness	Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.	3-hour period
Secondary	Maternal acceptance/perception of intervention	Maternal perception/acceptance of the bottles during a feeding assessed through a mixed methods interview.	3-hour period