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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT02359669 |
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Date of registration:
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26/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
Stimulearn |
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Scientific title:
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Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02359669 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Sudigdo Sastroasmoro, M.D, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
36 Months
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Behavioral: Without StimuLearn intervention
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Behavioral: StimuLearn Intervention
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Primary Outcome(s)
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Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)
[Time Frame: 24 weeks]
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Parent-rating of child's development
[Time Frame: 24 weeks.]
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Mother-Child interaction
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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