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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02207049
Other study ID # 9564 B
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee.


Description:

Providing snacks to children is widely recommended for appetite regulation and assisting with meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary intake in children than in previous years.2,3 Additionally, observational research has found that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy intake.3 However, no experimental studies examining the influence of snack intake on energy consumption in children have been conducted.2 Therefore, at this time it is not clear how snacks impact appetite regulation or energy intake, especially in young children. Thus, the purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating occasions over the course of a day for three sessions. To test the effects of providing snacks to preschoolers on consumption of food throughout the day, the food will be provided in three ways in the three different sessions: 1) children will be provided three meals (TM); 2) children will be provided three meals and two snacks, with total amount of food provided in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks with total amount provided in the meals equal to TM and total amount provided in the snacks equal to M+S (TM+S). Primary Hypothesis: 1) Energy consumed from food and beverages will be greatest during the TM+S session, followed by M+S, and then TM.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - 3 -to- 5 years of age - enrolled at the Early Learning Center for the full day program - have guardian consent to participate - like the foods served Exclusion Criteria: - have allergies or intolerances to the foods being served - not able to use a spoon - did not attend all feeding sessions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Snacking
Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
No Snacking
Caloric needs will be provided to preschoolers within three meals

Locations

Country Name City State
United States Healthy Eating and Activity Laboratory Knoxville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

References & Publications (2)

Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32. — View Citation

Ford CN, Slining MM, Popkin BM. Trends in dietary intake among US 2- to 6-year-old children, 1989-2008. J Acad Nutr Diet. 2013 Jan;113(1):35-42. doi: 10.1016/j.jand.2012.08.022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total calories of the food and beverages consumed. Total calories of food and beverage consumed by participants over the 3-week study (with 1 day of food and beverage per week) period will be determined by subtracting pre- and post-consumption weight of the food and beverage provided and multiplied by the energy density of each respective food and beverage. 3 weeks
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