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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108128
Other study ID # R21HD109362
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2023
Est. completion date May 31, 2025

Study information

Verified date March 2024
Source Temple University
Contact Christina Croce, MS
Phone 215-707-8672
Email christina.croce@temple.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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; color blindness 4. Child in foster care

Study Design


Intervention

Other:
Executive functioning observational tasks
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.

Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Temple University Baylor College of Medicine, University of Nevada, Reno

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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