Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358729
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-05
Brief Title:
Pre-Pregnancy Weight Loss and Baby Behavior Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple
Detailed Description:
The researchers will recruit babies from the original cohort in the PLAN study NCT03244722 regardless of which arms they participated in However the researchers will test the study arms from the original PLAN study for effects on the studys dependent variables Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention pre-pregnancy obesity with standard of care intervention and pre-pregnancy healthy weight with no intervention So although the researchers are not assigning babies to any arms their original assignment will still be assessed the study analysis
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