The study compared children without overweight/obesity, those with overweight/obesity and normal metabolic parameters, and those with overweight/obesity and metabolic abnormalities. Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a mixed-methods study that includes both co-creation workshops and an interventional component. The interventional part is a multicentre study conducted across six EU countries, involving a wi
(i) up to 8 years, (ii) 8-10 years, (iii) 10-14 years, (iv) 14-18 years) and cultural settings (minimum 24 participants per piloting county).
The clinical intervention will involve the validation of
Sponsors
University of Maribor
University Clinical Centre Maribor
National and Kapodistrian University of Athens
Karolinska Institutet
Blocks Health and Social Care EOOD
Vall d'Hebron Hospital Universitari
Centre Hospitalier Universitaire de Liège
Penteli General Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Ability to give informed consent 2. Owning a smartphone or tablet (available in the home environment, not necessarily a personal device of the participant) OR a parent owning a smartphone (for younger children) 3. Age: 5-18 years old 4. For the age group of 5-12 years old, parents will need to be involved, together with the children Inclusion into groups: For the study aims, children with overweight or obesity will be recruited based on criteria below: 1. Overweight: BMI more than 1 SD to 2 SD above the median of the WHO growth reference for children and adolescents 2. Obesity: BMI more than 2 SD above the median of the WHO growth reference for children and adolescents Further, the group will be stratified with children with overweight or obesity into two groups based on the IDF criteria: Children with overweight/obesity with normal metabolic parameters (CONM) Children with overweight/obesity with metabolic abnormalities (COMA) For children below 16 years old, one criterion needs to be fulfilled to classify for COMA group, for children 16 and above, two criteria need to be applied. The third, control group, will consist of children also recruited in a clinical setting, but with normal weight: Children without overweight/obesity (CWO): BMI up to 1 SD above the median of the WHO growth reference for children and adolescents
Exclusion criteria
Exclusion criteria: 1. Age under 5 years or above 18 years old 2. Severe mental disorder (schizophrenia, bipolar disorder, severe depressive disorder) 3. Inability to give informed consent and/or assent (e.g., in case of intellectual disability), by parents or children (age depending on the local legislation) 4. Severe cognitive disorder that would prevent following up on recommendations, and epileptic disorders 5. Children with severe chronic medical conditions 6. Orthopedic affliction limiting physical activity 7. Use of medication known to affect body weight 8. Known family issues that would affect general compliance and attendance at follow-up visits 9. Diagnosis of clinical condition that requires a specific diet (e.g. Coeliac disease, allergies,…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of new biological pathways conferring efficacy of preventive behavior measured using an epigenomic analysis of saliva collected at baseline and final check-up 2. Acceptability and usability of the mobile application and interventions measured through affective attitude (user experience) and participant engagement, trust and acceptance, the perceived burden of the behavior modifications and adherence using the Short Version of the User Experience Questionnaire (UEQ-S), the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) and the System Usability Scale (SUS) at T4 (during the first follow-up at the end of the supervised stage) and T5 (after the intervention ends) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity and specificity of defining the subsets of patients at risk for metabolic dysfunction measured using statistical analysis (ROC, AUC and k-fold cross-validation) comparing two classification approaches: (1) the computational classification generated by our Risk Assessment System and (2) the expert-determined metabolic status defined after T2 (stratification). The comparison will be performed after the last participant completes the study (after December 2026), establishing how accurately our computational model identifies at-risk patients relative to expert clinical assessment. The following assessments are made at baseline (T1) - Before the start of the interventions and at Final follow-up (T6) - 6 months after the participant entered the study: 2. Reduction in body weight of 5% or centiles of BMI by 5 percentile points or z-score BMI change by 0,25, reduction in body fat, reduction in other anthropometric parameters. The measurements will be taken in a controlled environment at clinical sites: Body weight measures using a calibrated scale; BMI calculated from height and weight measurements; body fat percentage using bioelectrical impedance analysis (BIA); waist and neck circumference using a measuring tape; and, height using Stadiometer. 3. Improvement of health/food literacy measured using a Food and Nutrition Literacy (FNLIT) 4. Improvement in quality of life measured using the KIDSCREEN-10 instrument 5. Improvement in well-being measured using the Child Well-being Index (WHO-5) 6. Increase in self-regulation measured using the Exercise Self-Regulation Questionnaire (SRQ-E), and the Self-Regulation of Eating Behaviour Questionnaire (SREBQ) 7. Decreased mental distress, including anxiety, depression, and self-perceived stigma measured using the Penn State Worry Questionnaire for Children (PSWQ-C), the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the Weight Self-Stigma Questionnaire (WSSQ) The following is assess | — |
Countries
Belgium, Bulgaria, Greece, Slovenia, Spain, Sweden
Contacts
Public ContactIzidor Mlakar
Outcome results
None listed