Obesity Clinical Trial
Official title:
Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old
Verified date | June 2024 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 22 |
Est. completion date | May 15, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 4 Years |
Eligibility | Inclusion Criteria: - healthy children Exclusion Criteria: - no food allergies - no medications that affect behavior/learning/appetite |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | salivary ghrelin levels | change in salivary ghrelin levels will be measured | change in salivary ghrelin from pre-lunch to 2-hours post lunch | |
Secondary | learning (working memory) | Head Toes Knee and Shoulders test | change from pre-lunch to 2-hours post lunch | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | anthropometric data | measured height and weight to calculate CDC BMI-for-age percentiles of body weight status | at baseline | |
Secondary | systolic and diastolic blood pressure | measured systolic and diastolic blood pressure | through study completion, on average of 8 weeks |
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