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

May 12, 2016 updated by: Société des Produits Nestlé (SPN)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jarkarta, Indonesia, 10430
        • Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Growing up milk (GUM)
GUM associated with StimuLearn intervention.
Behavioral: StimuLearn Intervention
  • StimuLearn apps
  • Cognitive questionnaires
Placebo Comparator: Skimmed Milk
Control group given skimmed milk without StimuLearn intervention.
Behavioral: Without StimuLearn intervention
Cognitive Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-rating of child's development
Time Frame: 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.
24 weeks.
Mother-Child interaction
Time Frame: 24 weeks
Interaction is videotaped for 10 minutes sequences and analyzed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).
24 weeks
Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)
Time Frame: 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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Sudigdo Sastroasmoro, M.D, Ph.D, Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13.11NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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