Development of Personalized Balanced Nutrition Concept Through an IT Platform

NCT ID: NCT05462444

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Child Allergy Allergic Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with food allergy

Skin prick test

Intervention Type OTHER

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

Children with food intolerance

Skin prick test

Intervention Type OTHER

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

Children with other allergies (reference group)

Skin prick test

Intervention Type OTHER

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

Interventions

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Skin prick test

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IN2 Ltd.

UNKNOWN

Sponsor Role collaborator

Children's Hospital Srebrnjak

OTHER

Sponsor Role lead

Responsible Party

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Mirjana Turkalj, MD

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Srebrnjak

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Mirjana Turkalj

Role: CONTACT

+38516391206

Facility Contacts

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Mirjana Turkalj, Prof,MD, PhD

Role: primary

+38516391206

Other Identifiers

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KK.01.1.1.07.0074

Identifier Type: -

Identifier Source: org_study_id

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