NCT05462444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.7 years

First QC Date

July 14, 2022

Last Update Submit

February 6, 2023

Conditions

Child AllergyAllergic Reaction

Keywords

AllergyPerosnalized nutritionObesity

Outcome Measures

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.

    33 months

Secondary Outcomes (1)

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

    33 months

Study Arms (3)

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

Skin prick testOTHER

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

Children with food allergyChildren with food intoleranceChildren with other allergies (reference group)

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Parental approval
  • Children from 1 to 6 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

HypersensitivityObesity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Immune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Central Study Contacts

Mirjana Turkalj

CONTACT

+38516391206mturkalj@bolnica-srebrnjak.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 18, 2022

Study Start

March 29, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

CR(1)