- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207049
The Effect of Snack Consumption on Energy Intake in Preschoolers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Three Meals (TM)
Preschoolers will be provided their caloric needs within three meals.
|
Caloric needs will be provided to preschoolers within three meals
|
Active Comparator: Meal plus Snack (M+S)
Preschoolers will be provided three meals and two snacks, with total amount of food provided in the day the same as the Three Meal (TM) arm.
|
Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
|
Active Comparator: Three Meal plus Snack (TM+S)
Preschoolers will be provided three meals and two snacks with total amount provided in the meals equal to the Three Meal (TM) arm and total amount provided in the snacks equal to Meal plus Snacks (M+S) arm.
|
Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total calories of the food and beverages consumed.
Time Frame: 3 weeks
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hollie A Raynor, PhD, RD, LDN, University of Tennesseem Knoxville
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 9564 B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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