Child AllergyNCT05462444
Development of Personalized Balanced Nutrition Concept Through an IT Platform
An observational study of Child Allergy and Allergic Reaction, run by Children's Hospital Srebrnjak at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Allergy, Allergic Reaction
- What is being tested?
- Skin prick test
- How many people
- 450 participants
- Where
- 1 siteCroatia
- Study dates
- 29 Mar 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will include a minimum of 450 preeschool children, aged 1-6 years, from Osijek, Split and Zagreb County.
Who may be able to join
- Parental approval
- Children from 1 to 6 years old
Who cannot join
- Chromosomal abberations
- Neurological disorders that affect oral motorics
- Chronic gastrointestinal disorders
- Severe metabolic disorders
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Children's Hospital Srebrnjak
Zagreb, 10000
Mirjana Turkalj, Prof,MD, PhD, +38516391206, mturkalj@bolnica-srebrnjak.hr
Mirjana Turkalj, Prof,MD, PhD
About this study
Official title: The Research and Development of the Personalized Balanced Nutrition Concept in Kindergartens Through an IT Platform
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:
- children who have a developed food allergy
- children at risk of developing mild, moderate or severe allergic reaction to food
- 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
- Child Allergy, Allergic Reaction
- Being tested
- Skin prick test
- Keywords
- Allergy, Perosnalized nutrition, Obesity
- Medical subject headings
- Hypersensitivity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick testOther
Skin prick test with a standard pallete of inhalational and nutritional allergens
| Study group | Role | What they receive |
|---|---|---|
| Children with food allergy | Not described Receives: Other: Skin prick test | |
| Children with food intolerance | Not described Receives: Other: Skin prick test | |
| Children with other allergies (reference group) | Not described Receives: Other: Skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start29 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Srebrnjak
- Sponsor type
- University, hospital or other
- Collaborators
- IN2 Ltd.
- Responsible party
- Principal investigator, Mirjana Turkalj, MD, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462444
- Sponsor's protocol ID
- KK.01.1.1.07.0074
- Status last verified
- Feb 2023
- First submitted
- 14 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research and Development of the Personalized Balanced Nutrition Concept in Kindergartens Through an IT Platform
- ClinicalTrials.gov ID
- NCT05462444
- Acronym / sponsor ID
- KK.01.1.1.07.0074
- Conditions
- Child Allergy, Allergic Reaction
- Keywords
- Allergy, Perosnalized nutrition, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Children's Hospital SrebrnjakUniversity, hospital or other
- Collaborators
- IN2 Ltd.
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- children who have a developed food allergy
- children at risk of developing mild, moderate or severe allergic reaction to food
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will include a minimum of 450 preeschool children, aged 1-6 years, from Osijek, Split and Zagreb County.
Key inclusion criteria (2 listed)
- Parental approval
- Children from 1 to 6 years old
Key exclusion criteria (4 listed)
- Chromosomal abberations
- Neurological disorders that affect oral motorics
- Chronic gastrointestinal disorders
- Severe metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin prick testSkin prick test with a standard pallete of inhalational and nutritional allergens | Other | Children with food allergy, Children with food intolerance, Children with other allergies (reference group) |
Primary outcome
Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens
Time frame: 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.
1 secondary outcome
Differentiation between children with allergies from chlidren's intolerance to food and development of a Register of Allergies
Time frame: 33 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Allergy and Allergic Reaction, run by Children's Hospital Srebrnjak at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjana Turkalj (+38516391206, mturkalj@bolnica-srebrnjak.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an IT platform for the introduction of personalized balanced nutrition in kindergartens (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.