The Effect of Snack Consumption on Energy Intake in Preschoolers
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 3, 2025
April 1, 2025
4.3 years
July 30, 2014
April 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Three Meals (TM)
ACTIVE COMPARATORPreschoolers will be provided their caloric needs within three meals.
Meal plus Snack (M+S)
ACTIVE COMPARATORPreschoolers 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.
Three Meal plus Snack (TM+S)
ACTIVE COMPARATORPreschoolers 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.
Interventions
Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
Caloric needs will be provided to preschoolers within three meals
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- have allergies or intolerances to the foods being served
- not able to use a spoon
- did not attend all feeding sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996, United States
Related Publications (3)
Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32.
PMID: 17111891BACKGROUNDSmith-Petersen MN, Larson CB, Cochran W. Local chemotherapy with primary closure of septic wounds by means of drainage and irrigation cannulae : M. N. Smith-Petersen MD (1886-1953), Carroll B. Larson MD, Williams Cochran MD . The 12th president of the AAOS 1943 (MNS-P). Clin Orthop Relat Res. 2008 Jan;466(1):104-12. doi: 10.1007/s11999-007-0023-4.
PMID: 18196379BACKGROUNDFord 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.
PMID: 23260722BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hollie A Raynor, PhD, RD, LDN
University of Tennesseem Knoxville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 1, 2014
Study Start
September 1, 2014
Primary Completion
December 31, 2018
Study Completion
December 31, 2025
Last Updated
April 3, 2025
Record last verified: 2025-04