- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723264
The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eating behavior activities
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1- 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary Intake
Time Frame: 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.
|
1- 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Lumeng, MD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00181248
- R01HD084163 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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