Healthy
Conditions
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.
Interventions
BEHAVIORALStimuLearn Intervention
* StimuLearn apps * Cognitive questionnaires
BEHAVIORALWithout StimuLearn intervention
Cognitive Questionnaires
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Months to 59 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
Countries
Indonesia
Outcome results
None listed