NCT06072638

Brief Summary

The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity. To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Dec 2023Jan 2028

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

October 7, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

October 2, 2023

Last Update Submit

October 1, 2025

Conditions

Eating Behavior

Keywords

eating behavior

Outcome Measures

Primary Outcomes (1)

  • Kilocalories consumed

    Up to approximately 36 months

Study Arms (1)

Eating in the Absence of Hunger (single arm)

EXPERIMENTAL

The researchers will enroll 150 children from the long-term observational study, NCT06039878.

Behavioral: Eating in Absence of Hunger

Interventions

Eating in Absence of HungerBEHAVIORAL

Researcher gives child free access to palatable foods following a satiating meal.

Eating in the Absence of Hunger (single arm)

Eligibility Criteria

Age0 Days+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
The child is a participant in the observational study (NCT06039878).

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

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Eating

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Julie Lumeng, MD

    University of Michigan

    STUDY CHAIR

Central Study Contacts

Alex Jeanpierre

CONTACT

734-531-9869ajeanp@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

December 21, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

October 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)