HealthyStimulearnNCT02359669
Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
A study testing StimuLearn Intervention and Without StimuLearn intervention in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- StimuLearn Intervention and Without StimuLearn intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital
Jarkarta, Jarkarta, 10430
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- StimuLearn Intervention, Without StimuLearn intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimuLearn InterventionBehavioural
- StimuLearn apps
- Cognitive questionnaires
Without StimuLearn interventionBehavioural
Cognitive Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Growing up milk (GUM) | Active comparator | GUM associated with StimuLearn intervention. Receives: Behavioral: StimuLearn Intervention |
| Skimmed Milk | Placebo comparator | Control group given skimmed milk without StimuLearn intervention. Receives: Behavioral: Without StimuLearn intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 weeks.
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).
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudigdo Sastroasmoro, M.D, Ph.D, Principal investigator, Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359669
- Sponsor's protocol ID
- 13.11NRC
- Acronym
- Stimulearn
- Status last verified
- Nov 2015
- First submitted
- 26 Jan 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30275398
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
- ClinicalTrials.gov ID
- NCT02359669
- Acronym / sponsor ID
- Stimulearn / 13.11NRC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growing up milk (GUM) | Active comparator | Behavioral: StimuLearn InterventionGUM associated with StimuLearn intervention. |
| Skimmed Milk | Placebo comparator | Behavioral: Without StimuLearn interventionControl group given skimmed milk without StimuLearn intervention. |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimuLearn Intervention* StimuLearn apps * Cognitive questionnaires | Behavioural | Growing up milk (GUM) |
| Without StimuLearn interventionCognitive Questionnaires | Behavioural | Skimmed Milk |
Primary outcome
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.
3 secondary outcomes
Parent-rating of child's development
Time frame: 24 weeks.
Mother-Child interaction
Time frame: 24 weeks
Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Derived from this study: PubMed 30275398Schneider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudigdo Sastroasmoro, M.D, Ph.D principal investigator
Center for Clinical Epidemiology and Evidence-based Medicine, Medical School, University of Indonesia-RSCM Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimuLearn Intervention and Without StimuLearn intervention in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.