Hunger and Learning Study in Preschoolers

Study Overview
=================
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.)

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

Conditions
-----------------
Hunger, Ingestive Behavior, Obesity, Food Preferences

Intervention / Treatment
-----------------
* Other: diet
* Other: usual diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children Exclusion Criteria: no food allergies no medications that affect behavior/learning/appetite

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

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 |