Development of Personalized Balanced Nutrition Concept Through an IT Platform

Recruiting

• Conditions: Child Allergy; Allergic Reaction
• Interventions: Other: Skin prick test

• Registration Number: NCT05462444
• Lead Sponsor: Children's Hospital Srebrnjak

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-29
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Parental approval
• Children from 1 to 6 years old

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with other allergies (reference group)	Skin prick test	-
Children with food allergy	Skin prick test	-
Children with food intolerance	Skin prick test	-

Primary Outcome Measures

Name	Time	Method
Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens	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.

Secondary Outcome Measures

Name	Time	Method
Differentiation between children with allergies from chlidren's intolerance to food and development of a Register of Allergies	33 months	The development of the Register of Allergies will provide pediatricians, general practitioners and specialists with personalized patient information which will ensure the application of appropriate health treatment and gudelines for identifying risk measures and allergic factors.

Trial Locations

Locations (1)

Children's Hospital Srebrnjak; 🇭🇷 Zagreb, Croatia