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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Infant Behavior; Obesity; Familial
• Intervention / Treatment: Behavioral: Typical Nipple; Behavioral: Challenging 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nipple order 1; First the typical nipple and then challenging nipple	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).
Experimental: Nipple order 2; First the challenging nipple and then the typical nipple	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suck effect	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sucking pressure	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks
Sucking frequency	Sucking will be measured with the NFANT® Feeding Solution	Up to 6 weeks
Milk/Formula intake		Up to 6 weeks
Milk/Formula consumption rate		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
Total Night Wake-ups within 24 hours of intervention		Up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Julie Lumeng, MD, University of Michigan; Principal Investigator: Amanda Crandall, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Child Behavior; Obesity; Infant Behavior
• Other Study ID Numbers: HUM00239775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The researchers may consider sharing data but hesitate due to difficulties de-identifying data of small samples. Please contact the study team if you have questions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No