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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: StimuLearn Intervention; Behavioral: Without StimuLearn intervention

• Registration Number: NCT02359669
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growing up milk (GUM)	StimuLearn Intervention	GUM associated with StimuLearn intervention.
Skimmed Milk	Without StimuLearn intervention	Control group given skimmed milk without StimuLearn intervention.

Primary Outcome Measures

Name	Time	Method
Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mother-Child interaction	24 weeks	Interaction is videotaped for 10 minutes sequences and analyzed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).
Parent-rating of child's development	24 weeks.	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.
Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)	24 weeks	This is a parent rated scale that obtains information about young children behaviors and is applicable for children aged 1.5 - 5 years.

Trial Locations

Locations (1)

Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital; 🇮🇩 Jarkarta, Indonesia