- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02111694
Influence of Bottle-Type on Infant Feeding Behaviors (OBS)
October 28, 2015 updated by: Drexel University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
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
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel University
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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
Yes
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant intake within a feeding (mL)
Time Frame: 3-hour period
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assessed by weighing the bottle before and after a feeding
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3-hour period
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Maternal responsiveness to infant cues during a feeding
Time Frame: 3-hour period
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assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale
|
3-hour period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal perception/acceptance of the bottles during a feeding
Time Frame: 3-hour period
|
3-hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alison K Ventura, PhD, Drexel University
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
- 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.
- Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.
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
June 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
April 7, 2014
First Posted (Estimate)
April 11, 2014
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 28, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBS-1303001967
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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