Clinical trial NCT05462444: Development of Personalized Balanced Nutrition Concept Through an IT Platform
Official title: The Research and Development of the Personalized Balanced Nutrition Concept in Kindergartens Through an IT Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Allergy
Allergic Reaction
Keywords: Allergy
Perosnalized nutrition
Obesity
Lead sponsor: Children's Hospital Srebrnjak
Sponsor class: OTHER
Collaborators: name: IN2 Ltd.
First posted: 2022-07-18
Enrollment: 450
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens
timeFrame: 33 months
Secondary outcomes:
measure: Differentiation between children with allergies from chlidren's intolerance to food and development of a Register of Allergies
timeFrame: 33 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Srebrnjak
Study officials:
References: