NCT06358729

Pre-Pregnancy Weight Loss and Baby Behavior Study

The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

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 study's 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.

Conditions

• Obesity; Familial
• Pregnancy Related
• Infant Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Typical Nipple	Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.
BEHAVIORAL	Challenging Nipple	Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).

Timeline

• Start date: 2025-02-13
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-04-11
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States