Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Study Overview
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Brief Summary
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This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.

Detailed Description
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This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.

Official Title
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Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition

Conditions
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Children, Under-nutrition

Intervention / Treatment
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* Other: nutritional supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child is between 36 and 48 months of age. Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile. Child is capable of oral feeding. Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period. Exclusion Criteria: Child whose either parent has BMI greater than or equal to 27.5 kg/m2. Child allergic or intolerant to any ingredient found in the study product. Child who was delivered pre-term. Child was born small for gestational Child had birth weight < 2500 g or > 4000 g. Child has current acute or chronic infections. Child demonstrates presence of severe gastrointestinal disorders. Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases. Child has a diagnosis of hormonal or metabolic disorders. Child has a congenital disease or genetic disorder. Child is diagnosed with infantile anorexia nervosa. Child has a developmental disability or physical disorder. Child has disorders of hemoglobin structure, function or synthesis. Child is participating in another study that has not been approved as a concomitant study.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 48 Months

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplement<br>Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided. | Other: nutritional supplement<br>* 2 servings per day<br>* Other names: Pediasure S229;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with recommendation of a nutritional supplement consumption |  | 48 weeks |