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Clinical Trials/NCT04723264
NCT04723264Active, not recruitingNot Applicable

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

University of Michigan2 sites in 1 country400 target enrollmentStarted: April 28, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
400
Locations
2
Primary Endpoint
Body Mass Index z - score (BMIz)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Eating behavior activities

Experimental

Intervention: Food protocols (Behavioral)

Outcomes

Primary Outcomes

Body Mass Index z - score (BMIz)

Time Frame: 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 Outcomes

  • Dietary Intake(1- 2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

University of Michigan

Study Sites (2)

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