Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-04
Brief Title:
Assessing Better Bottles for Babies
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Assessing Better Bottles for Babies AB3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AB3
Brief Summary:
This study will use a 2 x 2 factorial design to test impact of two intervention strategies bottle size and bottle opacity on infant weight gain
Detailed Description:
Infants who gain weight rapidly have over 4 times higher odds of developing obesity as a child or adult infants who are predominantly bottle-fed are at higher risk for excessive infancy weight gain and childhood obesity yet there are not effective interventions to reduce excessive weight gain among infants who are bottle-fed The investigators preliminary work suggest that two novel intervention strategies are feasible and may reduce excessive infancy weight gain reducing bottle size and increasing bottle opacity The investigators aim to test the independent and joint efficacy of these two intervention components among exclusively bottle-fed infants in a randomized full factorial clinical trial The investigators primary objective is to measure the change in conditional weight gain z-score CWGz from birth to four months by study group 4 groups are composed of two conditions smaller bottles and opaque bottles independently and in combination via a 2x2 factorial trial design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None