Pre-Pregnancy Weight Loss and Baby Behavior Study

Not Applicable

Not yet recruiting

• Conditions: Pregnancy Related; Obesity; Familial; Infant Behavior
• Interventions: Behavioral: Typical Nipple; Behavioral: Challenging Nipple

• Registration Number: NCT06358729
• Lead Sponsor: University of Michigan

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 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.

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Study Start: 2025-01
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nipple order 1	Challenging Nipple	First the typical nipple and then challenging nipple
Nipple order 2	Typical Nipple	First the challenging nipple and then the typical nipple
Nipple order 1	Typical Nipple	First the typical nipple and then challenging nipple
Nipple order 2	Challenging Nipple	First the challenging nipple and then the typical nipple

Primary Outcome Measures

Name	Time	Method
Suck effect	Up to 6 weeks	Sucking will be measured with the NFANT® Feeding Solution

Secondary Outcome Measures

Name	Time	Method
Total Night Wake-ups within 24 hours of intervention	Up to 6 weeks
Milk/Formula consumption rate	Up to 6 weeks
Sucking pressure	Up to 6 weeks	Sucking will be measured with the NFANT® Feeding Solution
Sucking frequency	Up to 6 weeks	Sucking will be measured with the NFANT® Feeding Solution
Milk/Formula intake	Up to 6 weeks
Number of Feedings Over 24 Hours	Up to 6 weeks
Total Hours of Sleep per 24 Hours within 24 hours of intervention	Up to 6 weeks

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States