Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growing up milk (GUM) | Active Comparator | GUM associated with StimuLearn intervention. |
|
| Skimmed Milk | Placebo Comparator | Control group given skimmed milk without StimuLearn intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimuLearn Intervention | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Mother-Child interaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sudigdo Sastroasmoro, M.D, Ph.D | Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital | Jarkarta | Jarkarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30275398 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Without StimuLearn intervention | Behavioral | Cognitive Questionnaires |
|
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) | 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 |