Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.
时间窗: 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.
次要结局
- Mother-Child interaction(24 weeks)
- Parent-rating of child's development(24 weeks.)
- Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)(24 weeks)