跳至主要内容
临床试验/NCT05462444
NCT05462444招募中不适用

The Research and Development of the Personalized Balanced Nutrition Concept in Kindergartens Through an IT Platform

Children's Hospital Srebrnjak1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens

研究概览

简要总结

By achieving effective cooperation between the Children's Hospital Srebrnjak (CHS), the Reference center for clinical allergology in children of the ministry of health, and IN2 Ltd., part of Constellation Software Inc., it is planned to develop an IT platform for the introduction of personalized balanced nutrition in kindergartens. The collected data which include the screening of the population, anthropometrical measurements, physical activity status, and medical examination, will be used to create a Registry of Allergies. Through the implementation of research activities, it is expected to develop an IT platform for personalized balanced nutrition of preschool children, which consists of a developed information system for continuous monitoring using a website and/or a mobile application.

详细描述

This study will involve kindergarten children (aged 1-6 years). The research takes place in six different phases: 1) development of the information system and data integration, 2) classification of target groups of kindergarten children according to nutritional status, 3) anthropometric monitoring of the development of kindergarten children, 4) establishment of an electronic register of allergies, 5) implementation of an information platform in kindergartens, and 6) assessment of the validity of platform. The research will include a minimum of 450 participants from Split, Osijek and Zagreb County. Based on the completed standardized questionnaires the target groups of kindergarten children will be classified according to their nutritional status:

  1. children who have a developed food allergy
  2. children at risk of developing mild, moderate or severe allergic reaction to food
  3. children with an allergological indication

The children with allergological indication (c) will be sent for further specialist evaluation, diagonstics and nutritionist advice at CHS.

The investigators will monitor how many kindergarten children have developed food allergy, food intolerance and another allergy (eg. inhalation allergy). Children with another type of allergy will be the refference control.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parental approval
  • Children from 1 to 6 years old

排除标准

  • Chromosomal abberations
  • Neurological disorders that affect oral motorics
  • Chronic gastrointestinal disorders
  • Severe metabolic disorders

结局指标

主要结局

Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens

时间窗: 33 months

IT platform will enable electronic creation and distribution of daily menus, daily collection of information about the food consumed, collecting relevant data and sending nutrition guidelines and instructions to kindergartens and parents.In addition to the above, the system will enable data collection of anthropometric measurements and monitoring of physical activity and send feedback to parents about measurement results. The mentioned system will, among other things, establish a communication link between the Children's Hospital Srebrnjak and kindergartens, which will enhance the exchange of data in real time and the possibility of timely adjustment of the menu.

次要结局

  • Differentiation between children with allergies from chlidren's intolerance to food and development of a Register of Allergies(33 months)

研究者

发起方
Children's Hospital Srebrnjak
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirjana Turkalj, MD

Professor, MD, PhD

Children's Hospital Srebrnjak

研究点 (1)

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