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

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04723264
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
400
1
1
45.2
8.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Food protocols
N/A

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
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
Actual Study Start Date :
Apr 28, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eating behavior activities

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Julie Lumeng, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT04723264
Other Study ID Numbers:
  • HUM00181248
  • R01HD084163
First Posted:
Jan 25, 2021
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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 Results

No Results Posted as of Mar 4, 2022