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

Study Overview
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Brief Summary
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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.

Official Title
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Self-served Snack Study for Preschool Children

Conditions
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Eating Behavior

Intervention / Treatment
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* Other: Snack with energy density less than 1.5 kcal/g
* Other: Snack with energy density greater than 1.5 kcal/g


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower-energy-dense Snack<br>Test snack with lower-energy-dense snack food | Other: Snack with energy density less than 1.5 kcal/g<br>* Snack meal with snack food having energy density less than 1.5 kcal/g<br>|
| Experimental: Higher-energy-dense Snack<br>Test snack with higher-energy-dense snack food | Other: Snack with energy density greater than 1.5 kcal/g<br>* Snack meal with snack food having energy density greater than 1.5 kcal/g<br>|

What is the study measuring?
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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 |