Hunger and Learning Study in Preschoolers

Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Food Preferences; Hunger; Ingestive Behavior
• Intervention / Treatment: Other: diet; Other: usual diet

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Elder; Phone Number: (434) 924-8570; Email: LJE5U@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Sibylle Kranz; Phone Number: 4349247904; Email: sibylle.kranz@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • Recruiting
      • University of Virginia
      • Contact: Sibylle Kranz, PhD; Phone Number: 434-924-7904; Email: sibylle.kranz@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy children

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diet; high fiber high protein foods served in childcare centers are offered for meals and snacks	Other: diet; foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial; Other Names: High protein high fiber
Other: usual diet; foods representing the usual diet in childcare centers are offered for meals and snacks	Other: usual diet; foods representing the usually provided foods at childcare are offered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hunger/fullness 120 minutes postprandial using "children's hunger scale"	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.	change on hunger/fullness scale from pre-lunch to 2-hours post lunch
salivary ghrelin levels	change in salivary ghrelin levels will be measured	change in salivary ghrelin from pre-lunch to 2-hours post lunch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
learning (working memory)	Head Toes Knee and Shoulders test	change from pre-lunch to 2-hours post lunch
physical activity level	children will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days	through study completion, on average of 8 weeks
liking of food	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).	through study completion, on average of 8 weeks
anthropometric data	measured height and weight to calculate CDC BMI-for-age percentiles of body weight status	at baseline
systolic and diastolic blood pressure	measured systolic and diastolic blood pressure	through study completion, on average of 8 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Sibylle Kranz, PhD, University of Virginia

Publications and helpful links

General Publications

• Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. 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. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.
• Kranz S, Marshall YW, Wight A, Bordi PL, Kris-Etherton PM. Liking and consumption of high-fiber snacks in preschool-age children. Food Quality and Preference 22: 486-489, 2011.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 23, 2024

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SBS 2018007700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No