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临床试验/NCT06109675
NCT06109675已完成不适用

Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status

Medipol University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Malnutrition rate in children with cystic fibrosis

研究概览

简要总结

The goal of this clinical trial is to to assess the nutritional status of children diagnosed with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition education given to the mothers of the patients on the nutritional status of the children and the nutritional knowledge of the mothers, and to compare them with the control group.. The main questions it aims to answer are:

  1. Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?
  2. Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education?
  3. Will the nutrition knowledge test scores of mothers of children with cystic fibrosis in education group on "Nutrition in Cystic Fibrosis" increase after nutrition education?

Mothers of children diagnosed with cystic fibrosis will participate in the study as a result of the call of the Cystic Fibrosis Association in Turkey. Mothers participating in the study will be divided into 2 groups. While the mothers in the first group will be given nutrition education 3 times a week, 1 hour a day, no education session will be given to the mothers in the control group. The nutritional status and nutrient consumption of children in the training group and the control group will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Mothers included in the research must have responded to the KIFDER (Cystic Fibrosis Association in Turkey) call.
  • Children of mothers included in the research must have been officially diagnosed with cystic fibrosis.
  • Mothers included in the research mustn't receive any nutrition education beforehand.
  • Children of mothers included in the research mustn't be regularly followed by a dietitian.

排除标准

  • Children of mothers included in the research mustn't have a feeding tube.
  • Children of mothers included in the research mustn't be diagnosed with any other disease known to affect growth.

结局指标

主要结局

Malnutrition rate in children with cystic fibrosis

时间窗: Beginning of the study, 1st and 3rd months of the study

According to the World Health Organisations (WHO) standarts; children who are more than 2 SD below the reference median are considered to be malnourished to be stunted, wasted or to be underweight. Children with measurements below 3 SD (a Z-Score of less than-3) are considered to be severely malnourished.

次要结局

  • The rate at which macronutrient and micronutrient consumption of children participating in the study meets the Recommended Dietary Allowance (RDA).(Beginning of the study, 1st and 3rd months of the study)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Pehlivan

Phd(c)

Medipol University

研究点 (1)

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