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

Eating Behavior Clinical Trial

Official title:

Self-served Snack Study for Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971811
• Other study ID #: ChildFood601
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: March 2022
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 3, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior

Intervention

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

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between interventions in the weight of self-served snack food	Weight served of snack food in grams	Study weeks 1 and 2
Primary	Difference between interventions in the weight of snack food consumed	Weight consumed of snack food in grams	Study weeks 1 and 2
Secondary	Difference between interventions in the volume of self-served snack food	Volume served of snack food in milliliters (ml)	Study weeks 1 and 2
Secondary	Difference between interventions in the volume of snack food consumed	Volume consumed of snack food in milliliters (ml)	Study weeks 1 and 2
Secondary	Difference between interventions in the energy of self-served snack food	Energy served of snack food in kilocalories (kcal)	Study weeks 1 and 2
Secondary	Difference between interventions in the energy of snack food consumed	Energy consumed of snack food in kilocalories (kcal)	Study weeks 1 and 2