The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
试验速览
- 阶段
- 不适用
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- linear growth rate
研究概览
简要总结
The purpose of this study is to determine and compare the effect of higher nutrient-dense complementary foods and standard nutrient dense complementary foods on the catch-up growth and nutritional status of stunting children aged 12-23 months old in Indonesia.
详细描述
This is an intervention, double blind study. Investigators want to study the effect of higher nutrient density complementary foods (which consists of optimizing children diet by practicing Optimized Complementary Feeding Recommendation/CFRs and consume special designed fortified biscuit) on catch-up growth and nutritional status of stunting children aged 12 - 23 mos old.
There are two phases in this study.
Phase I: Development of CFRs and fortified biscuit
- Food consumption survey (n=100) to gather information on foods typically consumed by the stunting children, food patterns, serving sizes, food price.
Methods: 24-hr dietary recall, food weighed dietary records (WDR) and 5-days food tally for each child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •identified as stunting (having HAZ ≤ -2SD of the WHO Growth Standard 2006)
- •no clinical evidence of any acute infectious disease or other diseases or morbidity condition that could interfere with the intake of study diets
- •parents and children residence in the study area.
- •parental concent obtained
排除标准
- •presence of oedema, severe illness warranting hospitalization on the enrolment day such as persistent diarrhea and other disease which may influence feeding practices and nutrient absorption
- •conncurrent participation in another clinical trial
- •severe anemia with hemoglobine concentration < 7.0 g/dL
结局指标
主要结局
linear growth rate
时间窗: one year
growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d
length gain
时间窗: one year
The increment of body length/height of the subjects, monthly measurement
次要结局
未报告次要终点
研究者
Duma Octavia Fransisca, MSc
PhD candidate
SEAMEO Regional Centre for Food and Nutrition