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

Not Applicable

Recruiting

• Conditions: Eating Behavior
• Interventions: Behavioral: Food protocols

• Registration Number: NCT04723264
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Study Start: 2021-04-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eating behavior activities	Food protocols	-

Primary Outcome Measures

Name	Time	Method
Body Mass Index z - score (BMIz)	1- 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Dietary Intake	1- 2 years	Mean dietary intake of macro- and micro-nutrients using an automated self-administered 24-hour dietary assessment tool across two recall days.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States