NCT04971811

Brief Summary

The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

July 20, 2021

Last Update Submit

March 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference between interventions in the weight of self-served snack food

    Weight served of snack food in grams

    Study weeks 1 and 2

  • Difference between interventions in the weight of snack food consumed

    Weight consumed of snack food in grams

    Study weeks 1 and 2

Secondary Outcomes (4)

  • Difference between interventions in the volume of self-served snack food

    Study weeks 1 and 2

  • Difference between interventions in the volume of snack food consumed

    Study weeks 1 and 2

  • Difference between interventions in the energy of self-served snack food

    Study weeks 1 and 2

  • Difference between interventions in the energy of snack food consumed

    Study weeks 1 and 2

Study Arms (2)

Lower-energy-dense Snack

EXPERIMENTAL

Test snack with lower-energy-dense snack food

Other: Snack with energy density less than 1.5 kcal/g

Higher-energy-dense Snack

EXPERIMENTAL

Test snack with higher-energy-dense snack food

Other: Snack with energy density greater than 1.5 kcal/g

Interventions

Snack meal with snack food having energy density less than 1.5 kcal/g

Lower-energy-dense Snack

Snack meal with snack food having energy density greater than 1.5 kcal/g

Higher-energy-dense Snack

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who are enrolled in a scheduled classroom of the participating childcare centers
  • Children who are between the ages of 4 and 6 years old at the time of enrollment

You may not qualify if:

  • Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
  • Children who are allergic to any of the foods served
  • Children whose diets exclude any of the foods served
  • Children who are absent from the childcare center on the acclimation day or both study days
  • Children who are not able to serve themselves the two foods that are provided during the acclimation day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Snacks

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 22, 2021

Study Start

September 15, 2021

Primary Completion

February 24, 2022

Study Completion

March 3, 2022

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations