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CompletedNCT04971811Updated Mar 21, 2022

Effects of Energy Density on Self-served Snacks in Preschool Children

An interventional study of Snack with energy density less than 1.5 kcal/g and Snack with energy density greater than 1.5 kcal/g in Eating Behavior, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Penn State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Eating Behavior
03

In context

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Lower-energy-dense Snack

    Test snack with lower-energy-dense snack food

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

  • Experimental
    Higher-energy-dense Snack

    Test snack with higher-energy-dense snack food

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

Interventions

  • OtherSnack with energy density less than 1.5 kcal/g

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

  • OtherSnack with energy density greater than 1.5 kcal/g

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

06

What researchers measure

Primary outcomes

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

    Weight served of snack food in grams

    Time frame: Study weeks 1 and 2

  2. Difference between interventions in the weight of snack food consumed

    Weight consumed of snack food in grams

    Time frame: Study weeks 1 and 2

Secondary outcomes

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

    Volume served of snack food in milliliters (ml)

    Time frame: Study weeks 1 and 2

  2. Difference between interventions in the volume of snack food consumed

    Volume consumed of snack food in milliliters (ml)

    Time frame: Study weeks 1 and 2

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

    Energy served of snack food in kilocalories (kcal)

    Time frame: Study weeks 1 and 2

  4. Difference between interventions in the energy of snack food consumed

    Energy consumed of snack food in kilocalories (kcal)

    Time frame: Study weeks 1 and 2

07

Study locations

1 site
  • The Pennsylvania State University
    University Park, Pennsylvania 16802, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04971811
Lead sponsor
Penn State University
Responsible party
Barbara J. Rolls (Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University) — Principal investigator
First posted
Jul 22, 2021
Start date
Sep 15, 2021
Primary completion
Feb 24, 2022
Completion
Mar 3, 2022
Last update
Mar 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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