Effects of Energy Density and Portion Size of Milk in Preschool Children

Study Overview
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Brief Summary
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In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.

Official Title
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Effects of Energy Density and Portion Size of Milk in Preschool Children

Conditions
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Feeding Behaviors

Intervention / Treatment
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* Behavioral: Low energy density
* Behavioral: High energy density
* Behavioral: Small portion
* Behavioral: Large portion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children must be enrolled in participating childcare centers Exclusion Criteria: Allergy or intolerance to any of the foods or beverages served

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low energy density, small portion<br>Low milk energy density and small portion size | Behavioral: Low energy density<br>* Low energy density milk served<br>Behavioral: Small portion<br>* Small portion of milk served<br>|
| Experimental: Low energy density, large portion<br>Low milk energy density and large portion size | Behavioral: Low energy density<br>* Low energy density milk served<br>Behavioral: Large portion<br>* Large portion of milk served<br>|
| Experimental: High energy density, small portion<br>High milk energy density and small portion size | Behavioral: High energy density<br>* High energy density milk served<br>Behavioral: Small portion<br>* Small portion of milk served<br>|
| Experimental: High energy density, large portion<br>High milk energy density and large portion size | Behavioral: High energy density<br>* High energy density milk served<br>Behavioral: Large portion<br>* Large portion of milk served<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between experimental conditions for milk, food, and total intake by weight | Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams) | once a week for 4 weeks | 
| Difference between experiential conditions for milk, food, and total intake by energy | Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal) | once a week for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal energy density | Meal energy density (energy density in kcal/g) | once a week for 4 weeks |