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临床试验/NCT03895164
NCT03895164Unknown不适用

Utilization of Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation for Stunting and Anemia Prevention Among Under-two Children

SEAMEO Regional Centre for Food and Nutrition4 个研究点 分布在 1 个国家目标入组 926 人开始时间: 2018年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
926
试验地点
4
主要终点
Change in hemoglobin status

研究概览

简要总结

Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
6 Months 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 6-11 months old at baseline
  • living in selected area during the study
  • apparently healthy
  • willing to take part in the study and taken venous blood sample by getting signed consent from parents

排除标准

  • the child does not present during venous blood sample collection

研究组 & 干预措施

Standard NE

Placebo Comparator

Control Group will receive standard nutrition education package from primary health care.

干预措施: Standard NE (Behavioral)

Enhanced NE

Experimental

Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation

干预措施: Enhanced NE (Behavioral)

结局指标

主要结局

Change in hemoglobin status

时间窗: At baseline before intervention (week 0), at endpoint after intervention (week 24)

to measure the change in hemoglobin (g/L) before and after intervention

Change in iron status

时间窗: At baseline before intervention (week 0), at endpoint after intervention (week 24)

to measure the change in serum ferritin (microgram/L) before and after intervention

Change in anthropometric measurements

时间窗: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

to measure the change in length measured by using WHO growth standard length-for-Age (Z-Score) before and after intervention period.

Change in zinc status

时间窗: At baseline before intervention (week 0), at endpoint after intervention (week 24)

to measure the change in serum zinc (mg/L) before and after intervention

次要结局

  • Change in dietary patterns(At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24))
  • Change in iron intake(At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24))
  • Change in zinc intake(At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24))
  • Change in calcium intake(At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Umi Fahmida

Principal Investigator

SEAMEO Regional Centre for Food and Nutrition

研究点 (4)

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