Hunger and Learning Study in Preschoolers

Not Applicable

Completed

• Conditions: Food Preferences; Hunger; Ingestive Behavior; Obesity
• Interventions: Other: diet; Other: usual diet

• Registration Number: NCT03861208
• Lead Sponsor: University of Virginia

Brief Summary

This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. Data are collected at the Diet and Nutrition (DAN) laboratory on repeated study days (8am - 4 pm).

Detailed Description

The investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. If preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. This study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch).

An important secondary outcome related to children's feelings of hunger is their ability to learn. Currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. This study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (Kranz S.et al. "High-Protein and High-Dietary-Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast" J Nutr doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (HTKS, KRISP, Stroop-style tasks, Woodcock Johnson vocabulary test, DCCS, and curisoty measures.)

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• healthy children

Exclusion Criteria

• no food allergies
• no medications that affect behavior/learning/appetite

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
diet	diet	high fiber high protein foods served in childcare centers are offered for meals and snacks
usual diet	usual diet	foods representing the usual diet in childcare centers are offered for meals and snacks

Primary Outcome Measures

Name	Time	Method
salivary ghrelin levels	change in salivary ghrelin from pre-lunch to 2-hours post lunch	change in salivary ghrelin levels will be measured
hunger/fullness 120 minutes postprandial using "children's hunger scale"	change on hunger/fullness scale from pre-lunch to 2-hours post lunch	hunger/fullness scale. change in children's perceived hunger and fullness on an age-appropriate scale: children respond to the question of "are you hungry or full" (coded hungry (1 or 2) or full (3 or 4)) followed by "are you very hungry( or full) or just a little hungry (or full)" coded as 1=very hungry, 2=a little hungry, 3- a little full, 4=very full, thus leading to a 4-point likert scale (from 1 to 4 with 1 being "very hungry" and 4 being "very full"). The development of the scale and its use are published by Kranz S. et al, Journal of Nutrition, 2017.

Secondary Outcome Measures

Name	Time	Method
learning (working memory)	change from pre-lunch to 2-hours post lunch	Head Toes Knee and Shoulders test
liking of food	through study completion, on average of 8 weeks	children will rate the foods provided using an age-appropriate visual (smiley faces) response coded as "like"(smiling face), "neutral" (face with straight line as mouth(, and "don't like" (face with tongue sticking out).
physical activity level	through study completion, on average of 8 weeks	children will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days
systolic and diastolic blood pressure	through study completion, on average of 8 weeks	measured systolic and diastolic blood pressure
anthropometric data	at baseline	measured height and weight to calculate CDC BMI-for-age percentiles of body weight status

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States