Skip to content

Using electronic health records and AI to improve health outcomes for children with obesity across Europe

Childhood Obesity Research and AI anaLysis on an EU-wide cohort (CORAL): an observational cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12357025
Enrollment
60
Registered
2024-10-15
Start date
2025-04-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood obesity Nutritional, Metabolic, Endocrine

Interventions

No direct interventions are performed
the study focuses on analyzing existing data to generate insights and predictive models for childhood obesity. This observational study involves the following key methodological components: Data Coll

Sponsors

University Medical Center Maribor
Lead Sponsor
University of Maribor
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the retrospective subjects: 1. Age of diagnosis between 5 and 18 years 2. (Overweight Cohort) BMI more than 1 SD to 2 SD above the median of the WHO growth reference for children and adolescents 3. (Obese Cohort): BMI more than 2 SD above the median of the WHO growth reference for children and adolescents 4. (Normal Weight Cohort) BMI up to 1 SD above the median of the WHO growth reference for children and adolescents Inclusion criteria for the healthcare professionals involved in the blind tests: 1. Must be professionally involved in the management of childhood obesity 2. Familiar with electronic health records and clinical decision support systems 3. Willingness to participate in the evaluation of the EU Childhood Obesity Platform 4. Ability to assess the feasibility, usability, and predictive power of AI/ML algorithms in clinical settings in two rounds Inclusion criteria for the researchers involved in the blind tests: 1. Experience in epidemiology of obesity, obesity research, or related fields 2. Must be engaged in clinical research on Big Data and/or obesity 3. Familiarity with AI/ML methodologies in healthcare applications 4. Ability to assess the feasibility, usability, and predictive power of AI/ML algorithms in clinical settings in two rounds

Exclusion criteria

Exclusion criteria: Exclusion criteria for blind test participants (healthcare professionals and researchers): 1. Unwillingness/inability to sign and Informed Consent 2. Participation in competing childhood obesity prediction or management platforms within the last 12 months 3. No current active involvement in clinical practice or research related to paediatrics or obesity management 4. Lack of basic digital literacy skills necessary to interact with the platform

Design outcomes

Primary

MeasureTime frame
1. Number of new obesity pathways discovered, as identified through machine learning analysis of the BIO-STREAMS dataset, measured at the end of the data analysis phase, evaluated at M30 (October 2025) and M42 (October 2026) 2. Sensitivity and specificity of the AI models for prediction of risks for obesity, compared to detailed clinical assessment, measured through blind tests on a 5-10% subset of the data at the end of the model validation phase, evaluated at M32 (December 2025), M44 (December 2026)

Secondary

MeasureTime frame
1. Usability of the EU Childhood Obesity Platform, measured using the System Usability Scale (SUS) completed by participating healthcare professionals and researchers at the end of each evaluation round, evaluated at M32 (December 2025), M44 (December 2026) 2. User acceptance of the EU Childhood Obesity Platform, assessed using a custom questionnaire based on the Technology Acceptance Model (TAM), completed by participating healthcare professionals and researchers at the end of each evaluation round, evaluated at M32 (December 2025), M44 (December 2026) 3. Quality and completeness of the homogenized retrospective BIO-STREAMS dataset, assessed using custom data quality metrics at the end of the data harmonization at M30 (October 2025) 4. Trust in AI predictions, measured using the Trust between People and Automation scale, completed by participating healthcare professionals and researchers at the end of each evaluation round, evaluated at M32 (December 2025), M44 (December 2026) 5. Cost-effectiveness of the EU Childhood Obesity Platform, calculated as the ratio of platform implementation costs to potential healthcare savings, estimated at the end of the study (April 2027, M48)

Countries

Belgium, Bulgaria, Greece, Slovenia, Spain, Sweden

Contacts

Public ContactAna Rehberger
ana.rehberger@um.si+386 (0)2 220 7267

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026