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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Growing up milk (GUM)

GUM associated with StimuLearn intervention.

Group Type ACTIVE_COMPARATOR

StimuLearn Intervention

Intervention Type BEHAVIORAL

* StimuLearn apps
* Cognitive questionnaires

Skimmed Milk

Control group given skimmed milk without StimuLearn intervention.

Group Type PLACEBO_COMPARATOR

Without StimuLearn intervention

Intervention Type BEHAVIORAL

Cognitive Questionnaires

Interventions

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StimuLearn Intervention

* StimuLearn apps
* Cognitive questionnaires

Intervention Type BEHAVIORAL

Without StimuLearn intervention

Cognitive Questionnaires

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

36 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes