Eat Healthy for Families

Study Overview
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Brief Summary
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This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.

Official Title
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Implementing a Dietary Energy Density Intervention in Preschool Children

Conditions
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Obesity, Childhood, Energy Density, Diet Quality

Intervention / Treatment
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* Behavioral: family-based obesity prevention lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity); the child is 2-5 years-old with a BMI-for-age and sex <95th percentile; the parent and child live together ≥50% of the time; the parent and child are able to read, speak and understand English; the family has transportation to the University of Delaware; and the family is committed to the 6-month program. Exclusion Criteria: the child is participating in a weight management program or seeing a Registered Dietitian for weight loss; the child is taking weight loss medication or medication that impacts appetite; or the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOW-ED<br>In the LOW-ED condition each participant will consume at least 10 low-ED foods/day (ED ≤1.0 kcal/g) and no more than 2 high ED foods/day (ED ≥3.0 kcal/g). Foods with an ED >1.0 kcal/g and <3.0 kcal/g will be unlimited; however, lowering the overall ED of the diet will be encouraged. | Behavioral: family-based obesity prevention lifestyle intervention<br>* A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.<br>|
| Active Comparator: STANDARD<br>In the STANDARD condition participants will consume the recommendations for calories, fruits, vegetables and whole grains based on age and sex corresponding with MyPlate. The daily caloric recommendations from MyPlate are for weight maintenance. | Behavioral: family-based obesity prevention lifestyle intervention<br>* A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Energy Density | Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated. | 6 months | 
| Energy Intake | Dietary intake will be analyzed using NDSR and energy intake will be calculated. | 6 months | 
| Dietary Quality | Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| zBMI | A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex. | 6 months |