Pre-Pregnancy Weight Loss and Baby Behavior Study

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358729
• Other study ID #: HUM00239775
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2027

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Amanda Crandall, PhD
• Phone: 734-647-8100
• Email: amkcrand[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

To be eligible to participate in this study...

Mother

-Current or previous participation in the PLAN study resulting in a live birth.

Child

• Mother participated in PLAN study during child's gestation

• Infant birth weight (From PLAN study records) appropriate (= 3rd percentile and = 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003).

• Infant is 3.0 to 6.0 months old at Consent.

• Biological mother is legal guardian by maternal report.

• Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time).

• Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report.

• Stated willingness by mother to comply with all study procedures and availability for the duration of the study.

Related Conditions & MeSH terms

• Infant Behavior
• Obesity; Familial
• Pregnancy Related
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suck effect	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks
Secondary	Sucking pressure	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks
Secondary	Sucking frequency	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks
Secondary	Milk/Formula intake		Up to 6 weeks
Secondary	Milk/Formula consumption rate		Up to 6 weeks
Secondary	Number of Feedings Over 24 Hours		Up to 6 weeks
Secondary	Total Hours of Sleep per 24 Hours within 24 hours of intervention		Up to 6 weeks
Secondary	Total Night Wake-ups within 24 hours of intervention		Up to 6 weeks