The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age

NCT ID: NCT04723264

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2026-07-31

Brief Summary

This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).

At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires

Detailed Description

This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.

Conditions

Eating Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Eating behavior activities

Group Type: EXPERIMENTAL

Food protocols

Intervention Type: BEHAVIORAL

Participants will engage in several activities (i.e. offering a variety of foods and age appropriate games, etc.) regarding eating behaviors.

Participants will be asked to videotape interactions using a secure system. An alternative option may be provided if this videotaping is not acceptable.

Interventions

Food protocols

Participants will engage in several activities (i.e. offering a variety of foods and age appropriate games, etc.) regarding eating behaviors.

Participants will be asked to videotape interactions using a secure system. An alternative option may be provided if this videotaping is not acceptable.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Prior participation in "The Development of Eating Behavior in Infancy" project
• Family lives within reasonable driving distance of the University of Michigan

Exclusion Criteria

• Significant developmental delays that would impede child's ability to participate
• Foster child
• Child has developed significant health problems that affect appetite, eating, or growth.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Julie Lumeng

Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School, Professor of Nutritional Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Lumeng, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Ventura AK, Ross KJ, Miller AL, DeJesus JM, Tan CC, Lumeng JC. Co-Development of Infant Satiation Cues and Maternal Feeding Behaviors during Infancy. Curr Dev Nutr. 2025 Sep 3;9(10):107542. doi: 10.1016/j.cdnut.2025.107542. eCollection 2025 Oct.

Reference Type: DERIVED

PMID: 41081012 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HD084163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00181248

Identifier Type: -

Identifier Source: org_study_id