Mother-Baby Study - Observational

NCT06039878 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-15

No results posted yet for this study

Summary

The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

Conditions

Interventions

BEHAVIORAL

Bonding-Evoked Oxytocin

Mother participates in bonding activity with infant at ages 1, 3, and 6 months

BEHAVIORAL

Distress Relieving Effects of Sucrose

Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition

BEHAVIORAL

Hedonic Response to Sucrose

Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months

BEHAVIORAL

Typical versus Challenging Feeding-Social

Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not.

BEHAVIORAL

Caloric Compensation-Social

Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not.

BEHAVIORAL

Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)

When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Michigan

    lead OTHER

Principal Investigators

  • Julie Lumeng, MD · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039878 on ClinicalTrials.gov