CClinicalTrials.gg
Status unknownNCT05462444Updated Feb 8, 2023

Development of Personalized Balanced Nutrition Concept Through an IT Platform

An observational study in Child Allergy and Allergic Reaction, sponsored by Children's Hospital Srebrnjak. Status unknown at 1 site in Croatia. Open to participants aged 1 Year to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Children's Hospital Srebrnjak · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
1 Year to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Allergy
  • Allergic Reaction

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Keywords

  • Allergy
  • Perosnalized nutrition
  • Obesity
03

In context

Hypersensitivity

1,914 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 450 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Children's Hospital Srebrnjak is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population will include a minimum of 450 preeschool children, aged 1-6 years, from Osijek, Split and Zagreb County.

Inclusion criteria

  • Parental approval
  • Children from 1 to 6 years old

Exclusion criteria

Exclusion Criteria:

  • Chromosomal abberations
  • Neurological disorders that affect oral motorics
  • Chronic gastrointestinal disorders
  • Severe metabolic disorders
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children with food allergy

    Other: Skin prick test

  • Children with food intolerance

    Other: Skin prick test

  • Children with other allergies (reference group)

    Other: Skin prick test

Interventions

  • OtherSkin prick test

    Skin prick test with a standard pallete of inhalational and nutritional allergens

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 33 months

Secondary outcomes

  1. Differentiation between children with allergies from chlidren's intolerance to food and development of a Register of Allergies

    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.

    Time frame: 33 months

07

Study locations

1 of 1 sites recruiting
  • Children's Hospital Srebrnjak
    Zagreb, 10000, Croatia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05462444
Lead sponsor
Children's Hospital Srebrnjak
Collaborators
IN2 Ltd.
Responsible party
Mirjana Turkalj, MD (Professor, MD, PhD, Children's Hospital Srebrnjak) — Principal investigator
First posted
Jul 18, 2022
Start date
Mar 29, 2021
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Mirjana Turkalj
Contact
mturkalj@bolnica-srebrnjak.com
+38516391206

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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