Clinical trial NCT02359669: Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
Official title: Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.
timeFrame: 24 weeks
Secondary outcomes:
measure: Parent-rating of child's development
timeFrame: 24 weeks.
measure: Mother-Child interaction
timeFrame: 24 weeks
measure: Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jarkarta
country: Indonesia
facility: Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital
Study officials:
affiliation: Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital
name: Sudigdo Sastroasmoro, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider N, Geiser E, Gosoniu LM, Wibowo Y, Gentile-Rapinett G, Tedjasaputra MS, Sastroasmoro S. A Combined Dietary and Cognitive Intervention in 3(-)5-Year-Old Children in Indonesia: A Randomized Controlled Trial. Nutrients. 2018 Oct 1;10(10):1394. doi: 10.3390/nu10101394.