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

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Behavioral: Without StimuLearn intervention; Behavioral: StimuLearn Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02359669

13.11NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 36 to 59 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups, including a placebo group

Growing up milk (GUM)

Active Comparator group

Description:

GUM associated with StimuLearn intervention.

Treatment:

Behavioral: StimuLearn Intervention

Skimmed Milk

Placebo Comparator group

Description:

Control group given skimmed milk without StimuLearn intervention.

Treatment:

Behavioral: Without StimuLearn intervention