Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
研究概览
简要总结
This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting.
Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention
Objectives:
To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children.
Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).
详细描述
The stunted children will receive an intervention package which includes food supplementation (FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly for 6 months. The control children will receive routine clinical care but no FS and PS. Routine clinical care includes micronutrients powder, de-worming, health and nutrition education and immunization. All children will be assessed for appetite score (ECAST score) and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly for 3 months, and cognitive development using Bayley Scales of Infant and Toddler Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment. Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin percentage.
Stool samples will be collected for routine examination and stool biomarkers. Urine sample will be collected for screening urinary tract infection. All the specimens will be collected at baseline and at 3 and 6 months of enrollment.
Outcome measures/variables:
The primary outcome:
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 stunted children (LAZ<-2) aged 12-18 months
- •50 non-stunted (LAZ≥-2) aged 12-18 months
排除标准
- •Severe acute malnutrition (SAM)
- •Chronic illness
- •Congenital anomaly/developmental delay/oromotor dysfunction
结局指标
主要结局
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
时间窗: 4 months
次要结局
- Association of appetite score with growth and development child food intake(15 months)
- Association of appetite score with growth and potential biomarkers of appetite(15 months)
- Association of appetite score with growth and intestinal inflammation of the children(15 months)