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

This study is currently recruiting participants.
Verified April 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Paula Chandler-Laney, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01526018
First received: January 31, 2012
Last updated: April 22, 2013
Last verified: April 2013

January 31, 2012
April 22, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
Food intake [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Rate of intake, volume of intake, duration of meal
Body fat [ Time Frame: Two-weeks ] [ Designated as safety issue: No ]
Measured by air-displacement plethysmography
Complete list of historical versions of study NCT01526018 on ClinicalTrials.gov Archive Site
Not Provided
Food intake [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Free-living volume of formula intake; rate, duration and volume of intake during meal test in the clinic.
Not Provided
Not Provided
 
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Bottle-fed infants aged 1-6 months

Infant Feeding Behavior
Behavioral: 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.
Novel bottle
Intervention: Behavioral: Podee bottle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
1 Month to 6 Months
Yes
Contact: Paula Chandler-Laney, PhD 205-934-0809 pchandle@uab.edu
United States
 
NCT01526018
F110921001
No
Paula Chandler-Laney, PhD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Not Provided
University of Alabama at Birmingham
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP