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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04723264
Other study ID # HUM00181248
Secondary ID R01HD084163
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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