- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06108128
Food for Thought: Executive Functioning Around Eating Among Children
April 7, 2025 updated by: Jennifer Orlet Fisher, Temple University
Characterizing Top-down Dimensions of Appetite Self-regulation Among Preschoolers
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited.
This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Appetite self-regulation (ASR) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat.
Much of the research to date on ASR has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity.
Alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood.
The goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down ASR.
Participants will be 125 preschoolers and their primary caregiver.
Existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down ASR.
Associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.
Study Type
Interventional
Enrollment (Estimated)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Croce, MS
- Phone Number: 215-707-8672
- Email: christina.croce@temple.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Recruiting
- Temple University
-
Contact:
- Christina Croce, MS
- Phone Number: 215-707-8672
- Email: christina.croce@temple.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Study Population
Community sample of urban preschool aged children and their primary caregivers will be recruited in Philadelphia, PA.
Description
Inclusion Criteria:
- Child ages 4 to 6 years of age
- Caregiver reporting primary responsibility for child feeding outside of childcare
- Caregiver legal guardian
Exclusion Criteria:
- Caregiver <18 years of age
- Child major food allergies
- Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness
- Child in foster care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food choice
Time Frame: Assessed at 1 of 2 study visits over 2 weeks
|
Children's forced-choice selection of fruits, vegetables, and water over alternatives at a meal
|
Assessed at 1 of 2 study visits over 2 weeks
|
|
Eating in the absence of hunger
Time Frame: Assessed at 1 of 2 study visits over 2 weeks
|
Children's intake of palatable foods following a standard meal
|
Assessed at 1 of 2 study visits over 2 weeks
|
|
Body mass index z-score
Time Frame: Assessed at 1 of 2 study visits over 2 weeks
|
Age and sex specific z-score using CDC reference data
|
Assessed at 1 of 2 study visits over 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer O Fisher, PhD, Temple University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HD109362 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University.
This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire.
TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements.
It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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