NCT02207049

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

July 30, 2014

Last Update Submit

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 COMPARATOR

Preschoolers will be provided their caloric needs within three meals.

Behavioral: No Snacking

Meal plus Snack (M+S)

ACTIVE COMPARATOR

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.

Behavioral: Snacking

Three Meal plus Snack (TM+S)

ACTIVE COMPARATOR

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.

Behavioral: Snacking

Interventions

SnackingBEHAVIORAL

Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs

Meal plus Snack (M+S)Three Meal plus Snack (TM+S)
No SnackingBEHAVIORAL

Caloric needs will be provided to preschoolers within three meals

Three Meals (TM)

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

Related Publications (3)

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

    PMID: 17111891BACKGROUND
  • Smith-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: 18196379BACKGROUND
  • 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.

    PMID: 23260722BACKGROUND

MeSH Terms

Interventions

Snacks

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hollie A Raynor, PhD, RD, LDN

    University of Tennesseem Knoxville

    PRINCIPAL INVESTIGATOR

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

Locations