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

Healthy Clinical Trial

— Stimulearn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359669
• Other study ID #: 13.11NRC
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: May 12, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• StimuLearn Intervention
StimuLearn apps Cognitive questionnaires
• Without StimuLearn intervention
Cognitive Questionnaires

Locations

Country	Name	City	State
Indonesia	Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital	Jarkarta

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Indonesia, 

Outcome

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