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临床试验/NCT05878886
NCT05878886已完成不适用

Effect of Mangrove-sword Bean-food Bar on the Weight and Weight-for-Age Z Score of Under-five Children Affected by Landslide Disaster. The Pre-post Intervention Study Towards 34 Under-five Children During 15 Days

Indonesia University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Effect of mangrove-sword bean-food bar on the weight and Weight-for-Age Z score (WAZ) of under-five children affected by landslide disaster

研究概览

简要总结

The goal of this clinical trial is to assess the effect of the food bar made from api-api mangrove (Avicennia marina) and sword bean (Canavalia ensiformis) blends on the weight and Weight-for-Age Z score affected by a landslide disaster.

The main questions aimed to answer are:

  • Food bar supplementation can effect the weight and WAZ score of under-five children affected by landslides disaster?
  • Balanced nutrition education can increase the mothers' knowledge on the balanced nutrition of under-five children?

Participants divided in to two group i.e.:

  • Treatment/intervention group consumed 50 g mangrove sword bean food bar each day during 15 days.
  • Control group consumed 50 g sword bean food bar each day during 15 days.
  • Each group received balanced nutrition for mothers once at the first week of study.

详细描述

Eligibility Criteria for Under-five children:

  • Aged between 12 and 59 months
  • Male and female
  • Living in Cihanjuang Village of Sumedang District which affected by the landslide disaster
  • Had malnutrition, normal, or over-nutrition status, and not suffering from infectious diseases.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

All subjects at treatment group given mangrove sword bean food bar during 15 days to examine their weight and WAZ score at pre-post study.

入排标准

年龄范围
12 Months 至 49 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 12 and 59 months
  • Male and female living in Cihanjuang Village of Sumedang District who affected by the landslide disaster
  • Had malnutrition, normal, or over-nutrition status
  • Not suffering from infectious diseases
  • Willing to avoid consumption of any snacks other than the food bars and plain water

排除标准

  • Suffered from infectious or chronical diseases

结局指标

主要结局

Effect of mangrove-sword bean-food bar on the weight and Weight-for-Age Z score (WAZ) of under-five children affected by landslide disaster

时间窗: Two weeks

Change of weight measured by digital weighing. Change of Weight for Age Z score measured by using Nutri Survey Software. Mean difference of weight and Weight-for-Age Z score were calculated as the value at two weeks minus the value at baseline.

次要结局

  • Change of mothers' balanced nutrition knowledge(Two weeks)

研究者

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

Fatmah Fatmah

Principal Investigator

Indonesia University

研究点 (1)

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