- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06108128
Food for Thought: Executive Functioning Around Eating Among Children
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Caregiver-child dyads
Observational study of executive functioning around eating and parenting |
Interventions take place solely at the measurement level, where children will be seen in observational tasks of general executive functioning and executive functioning around eating in which various food and non-food stimuli are presented and children's responses to task instructions are recorded. |
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
Sponsor
Investigators
- Principal Investigator: Jennifer O Fisher, PHD, Temple University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
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)?
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
Studies a U.S. FDA-regulated device product
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