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

October 8, 2018 updated by: Alison Ventura, California Polytechnic State University-San Luis Obispo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93401
        • California Polytechnic State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant intake
Time Frame: 3-hour period
Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.
3-hour period
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.
3-hour period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Investigators

  • Principal Investigator: Alison K Ventura, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 00000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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