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

NCT ID: NCT01526018

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Infant Feeding Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Novel bottle

Podee bottle

Intervention Type: BEHAVIORAL

Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.

Interventions

Podee bottle

Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Paula Chandler-Laney, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F110921001

Identifier Type: -

Identifier Source: org_study_id