NCT04723264

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Apr 2021Jul 2026

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

January 20, 2021

Last Update Submit

April 27, 2026

Conditions

Keywords

Body mass indexDietary qualityChildren

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index z - score (BMIz)

    Children will be weighed and measured using a portable stadiometer. BMI will be calculated and child BMI z-score derived using age- and sex-specific norms from Centers for Disease Control and Prevention (CDC) growth charts.

    1- 2 years

Secondary Outcomes (1)

  • Dietary Intake

    1- 2 years

Study Arms (1)

Eating behavior activities

EXPERIMENTAL
Behavioral: Food protocols

Interventions

Food protocolsBEHAVIORAL

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.

Eating behavior activities

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Julie Lumeng, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

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, Associate Dean for Research, Medical School, Professor of Nutritional Sciences

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

April 28, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The research will generate demographic, behavioral, videorecorded, and anthropometric data. (Note the researchers will not make video data available). Meta data will also be included in the selected repositories. Of note, this will include only child age, but not birthdate or date of study visit as these would violate confidentiality. The metadata will include the data dictionaries, which describe the generation of all variables.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
We will make the de-identified data available within one year of completion of the study at the University of Michigan's data repository (Deep Blue Data Repository). We will not place video/audio data in the data repository due to the inability to de-identify the participants and protect their privacy
Access Criteria
All data in the Deep Blue Data repository are available to anyone for download without restriction.

Locations