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

Self-served Snack Study for Preschool Children

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.

Study Overview

• Status: Completed
• Conditions: Eating Behavior
• Intervention / Treatment: Other: Snack with energy density less than 1.5 kcal/g; Other: Snack with energy density greater than 1.5 kcal/g

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower-energy-dense Snack; Test snack with lower-energy-dense snack food	Other: Snack with energy density less than 1.5 kcal/g; Snack meal with snack food having 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; Snack meal with snack food having energy density greater than 1.5 kcal/g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between interventions in the volume of self-served snack food	Volume served of snack food in milliliters (ml)	Study weeks 1 and 2
Difference between interventions in the volume of snack food consumed	Volume consumed of snack food in milliliters (ml)	Study weeks 1 and 2
Difference between interventions in the energy of self-served snack food	Energy served of snack food in kilocalories (kcal)	Study weeks 1 and 2
Difference between interventions in the energy of snack food consumed	Energy consumed of snack food in kilocalories (kcal)	Study weeks 1 and 2

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ChildFood601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No