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

NCT ID: NCT04971811

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-03-03

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.

Conditions

Eating Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lower-energy-dense Snack

Test snack with lower-energy-dense snack food

Group Type: EXPERIMENTAL

Snack with energy density less than 1.5 kcal/g

Intervention Type: OTHER

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

Higher-energy-dense Snack

Test snack with higher-energy-dense snack food

Group Type: EXPERIMENTAL

Snack with energy density greater than 1.5 kcal/g

Intervention Type: OTHER

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

Interventions

Snack with energy density less than 1.5 kcal/g

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Barbara J. Rolls

Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

ChildFood601

Identifier Type: -

Identifier Source: org_study_id