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

Eating Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723264
• Other study ID #: HUM00181248
• Secondary ID: R01HD084163
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Alex Jeanpierre
• Phone: 734-647-1126
• Email: ajeanp[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria for Children (ages 5-7.99) and their parents (18 and older):

• 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.

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dietary Intake	Mean dietary intake of macro- and micro-nutrients using an automated self-administered 24-hour dietary assessment tool across two recall days.	1- 2 years