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

Société des Produits Nestlé (SPN)200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

200

Conditions

Healthy

Interventions

StimuLearn InterventionBEHAVIORAL

* StimuLearn apps * Cognitive questionnaires

Without StimuLearn interventionBEHAVIORAL

Cognitive Questionnaires

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 59 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital

Jarkarta, Jarkarta, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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