Pre-Pregnancy Weight Loss and Baby Behavior Study

NCT06358729 | Completed

• 1 other identifier: HUM00239775
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Familial; Pregnancy Related; Infant Behavior

Outcome Measures

Primary Outcomes (1)

• Suck effect

  Sucking will be measured with the NFANT® Feeding Solution

  Up to 6 weeks

Secondary Outcomes (7)

• Sucking pressure

  Up to 6 weeks

• Sucking frequency

  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

Study Arms (2)

Nipple order 1

EXPERIMENTAL

First the typical nipple and then challenging nipple

Behavioral: Typical Nipple; Behavioral: Challenging Nipple

Nipple order 2

EXPERIMENTAL

First the challenging nipple and then the typical nipple

Behavioral: Typical Nipple; Behavioral: Challenging Nipple

Interventions

Typical Nipple BEHAVIORAL

Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.

Nipple order 1; Nipple order 2

Challenging Nipple BEHAVIORAL

Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).

Nipple order 1; Nipple order 2

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity; Infant Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Behavior; Behavior

Study Officials

• Amanda Crandall, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Julie Lumeng, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow, Pediatrics

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 11, 2024
• Study Start: February 13, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 22, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)