The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

Terminated

• Conditions: Infant Feeding Behavior
• Interventions: Behavioral: Podee bottle

• Registration Number: NCT01526018
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
• parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.

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Exclusion Criteria

• born < 37 weeks;
• birth weight < 2500g or > 4000g;
• current weight < 10th percentile for age;
• hospitalization > 72 hours following birth or any hospital admission since birth;
• any health issue that could interfere with feeding and/or growth;
• use of complementary foods;
• inability or unwillingness to comply with study-related procedures.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novel bottle	Podee bottle	-

Primary Outcome Measures

Name	Time	Method
Food intake	2 weeks	Rate of intake, volume of intake, duration of meal

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States