NCT02359669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 13, 2016

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

January 26, 2015

Last Update Submit

May 12, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Parent-rating of child's development

    24 weeks.

  • Mother-Child interaction

    24 weeks

  • Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)

    24 weeks

Study Arms (2)

Growing up milk (GUM)

ACTIVE COMPARATOR

GUM associated with StimuLearn intervention.

Behavioral: StimuLearn Intervention

Skimmed Milk

PLACEBO COMPARATOR

Control group given skimmed milk without StimuLearn intervention.

Behavioral: Without StimuLearn intervention

Interventions

StimuLearn InterventionBEHAVIORAL

* StimuLearn apps * Cognitive questionnaires

Growing up milk (GUM)
Without StimuLearn interventionBEHAVIORAL

Cognitive Questionnaires

Skimmed Milk

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jarkarta, Jarkarta, 10430, Indonesia

Location

Related Publications (1)

  • Schneider N, Geiser E, Gosoniu LM, Wibowo Y, Gentile-Rapinett G, Tedjasaputra MS, Sastroasmoro S. A Combined Dietary and Cognitive Intervention in 3(-)5-Year-Old Children in Indonesia: A Randomized Controlled Trial. Nutrients. 2018 Oct 1;10(10):1394. doi: 10.3390/nu10101394.

    PMID: 30275398DERIVED

Study Officials

  • Sudigdo Sastroasmoro, M.D, Ph.D

    Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 10, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 13, 2016

Record last verified: 2015-11

Locations

ID(1)