NCT06108128

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

October 24, 2023

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Food choice

    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

    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

    Age and sex specific z-score using CDC reference data

    Assessed at 1 of 2 study visits over 2 weeks

Interventions

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.

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child ages 4 to 6 years of age
  • Caregiver reporting primary responsibility for child feeding outside of childcare
  • Caregiver legal guardian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (1)

  • Russell CG, Russell A. "Food" and "non-food" self-regulation in childhood: a review and reciprocal analysis. Int J Behav Nutr Phys Act. 2020 Mar 10;17(1):33. doi: 10.1186/s12966-020-00928-5.

    PMID: 32151265BACKGROUND

MeSH Terms

Conditions

Self-ControlAppetitive BehaviorFeeding BehaviorPediatric Obesity

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavior, AnimalObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer O Fisher, PHD

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Croce, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is an observational cross-sectional study with interventions ONLY at the measurement level. The research assistant administers the tasks and records the outcomes; therefore, no masking is used.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is an observational, cross-sectional study that involves interventions ONLY at the measurement level.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

October 5, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Locations