Food for Thought: Executive Functioning Around Eating Among Children

• Sponsor: Temple University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06108128
• Collaborator: Baylor College of Medicine (Other), Northern Illinois University (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 18.8
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Self-regulation; Appetitive Behavior; Eating Behavior; Child Obesity	Other: Executive functioning observational tasks

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 150 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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Characterizing Top-down Dimensions of Appetite Self-regulation Among Preschoolers
• Actual Study Start Date: Oct 5, 2023
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Apr 30, 2025

Outcome Measures

Primary Outcome Measures

1. Food choice [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

2. Eating in the absence of hunger [Assessed at 1 of 2 study visits over 2 weeks]

   Children's intake of palatable foods following a standard meal

3. Body mass index z-score [Assessed at 1 of 2 study visits over 2 weeks]

   Age and sex specific z-score using CDC reference data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Child ages 4 to 6 years of age

2. Caregiver reporting primary responsibility for child feeding outside of childcare

3. Caregiver legal guardian

Exclusion Criteria:

1. Caregiver <18 years of age

2. Child major food allergies

3. Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth

4. Child in foster care

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• Baylor College of Medicine
• Northern Illinois University

Investigators

• Principal Investigator: Jennifer O Fisher, PHD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Jennifer Orlet Fisher, Professor, Temple University
• ClinicalTrials.gov Identifier: NCT06108128
• Other Study ID Numbers: R21HD109362
• First Posted: Oct 30, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• 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
• Additional relevant MeSH terms: Pediatric Obesity

Study Results

No Results Posted as of Nov 1, 2023