Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities

Study Overview
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Brief Summary
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The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments.

Detailed Description
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The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments with HOME score less than 26. The control group will receive skimmed milk but no extra stimulation materials ( however, no restrictions on normal mother-child interaction). The cognitive abilities, mother-child interaction and child behavior will be assessed after a 6 months intervention.

Official Title
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Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: StimuLearn Intervention
* Behavioral: Without StimuLearn intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female children, age 3;0-4;11 years Having obtained their legal representative's informed consent Level of stimulation in their home environment score below 26 in HOME inventory Normal cognitive development Exclusion Criteria: Neurological disorders Food allergies (especially milk and soy allergy) Documented lactose intolerance Children with special nutritional needs Children under chronic (more than 7 consecutive days) medications which may impact cognitive performance Children not living in a family/children in foster homes Subject who cannot be expected to comply with study procedures Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 59 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Growing up milk (GUM)<br>GUM associated with StimuLearn intervention. | Behavioral: StimuLearn Intervention<br>* StimuLearn apps Cognitive questionnaires<br>|
| Placebo Comparator: Skimmed Milk<br>Control group given skimmed milk without StimuLearn intervention. | Behavioral: Without StimuLearn intervention<br>* Cognitive Questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition. | Blind assessment achieved by dedicated pyschologists at test center through use of the Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition questionnaire. This test is aimed at measuring overall cognitive abilities. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-rating of child's development | Measured by the Ages & Stages Questionnaire ( ASQ-3) which is a questionnaire for different age stages between 2 and 66 months of age to screen areas of communication, gross motor, fine motor, problem-solving and personal-social skills. | 24 weeks. | 
| Mother-Child interaction | Interaction is videotaped for 10 minutes sequences and analyzed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO). | 24 weeks | 
| Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years) | This is a parent rated scale that obtains information about young children behaviors and is applicable for children aged 1.5 - 5 years. | 24 weeks |