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Hunger and Learning Study in Preschoolers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03861208
Enrollment
22
Registered
2019-03-04
Start date
2018-07-01
Completion date
2024-05-15
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hunger, Ingestive Behavior, Obesity, Food Preferences

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.)

Interventions

OTHERdiet

foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial

foods representing the usually provided foods at childcare are offered

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy children

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
hunger/fullness 120 minutes postprandial using children's hunger scalechange on hunger/fullness scale from pre-lunch to 2-hours post lunchhunger/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.
salivary ghrelin levelschange in salivary ghrelin from pre-lunch to 2-hours post lunchchange in salivary ghrelin levels will be measured

Secondary

MeasureTime frameDescription
liking of foodthrough study completion, on average of 8 weekschildren 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).
learning (working memory)change from pre-lunch to 2-hours post lunchHead Toes Knee and Shoulders test
systolic and diastolic blood pressurethrough study completion, on average of 8 weeksmeasured systolic and diastolic blood pressure
anthropometric dataat baselinemeasured height and weight to calculate CDC BMI-for-age percentiles of body weight status
physical activity levelthrough study completion, on average of 8 weekschildren will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026