Healthy Clinical Trial
— StimulearnOfficial title:
Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
Verified date | November 2015 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 36 Months to 59 Months |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Indonesia | Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital | Jarkarta |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 weeks | No |
Secondary | 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. | 24 weeks. | No |
Secondary | 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). | 24 weeks | No |
Secondary | 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. | 24 weeks | No |
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