Feasibility study of a personalized recommendation system for obesity prevention: a mixed methods approach
| ISRCTN | ISRCTN44876661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44876661 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HORIZON EUROPE Health GA No. 101080718 |
| 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 |
| Funder | HORIZON EUROPE Health |
- Submission date
- 12/03/2025
- Registration date
- 23/04/2025
- Last edited
- 20/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Childhood obesity is a growing health challenge worldwide. The BIO-STREAMS project aims to tackle this by testing a personalized digital program designed to help children and families adopt healthier lifestyles. The digital intervention includes a mobile app, serious games, and tailored advice based on each child’s habits, genetic background, and metabolism. The study will also understand how genes and environmental factors influence how well these lifestyle and behavioral changes work.
Who can participate?
Children and adolescents aged 5–18 years old from six European countries (Slovenia, Spain, Greece, Sweden, Belgium, Bulgaria). Parents of younger children (5–12 years) will also take part.
What does the study involve?
Participants are divided into three groups:
1. Children without overweight/obesity (CWO)
2. Children with overweight/obesity but normal metabolism (CONM)
3. Children with overweight/obesity and metabolic health issues (e.g., high blood sugar or cholesterol) (COMA)
Co-creation workshops: Children help design the app and games by sharing feedback on features from the mobile application, study design and concepts such as avatars, quizzes, and exercise plans.
6-month intervention: The participants undergo a 6-month intervention with personalized lifestyle recommendations delivered through digital tools, without randomization or masking, and no control group in the traditional sense, but rather a comparison across different participant groups.
First 2 months: Baseline assessment, including body measurements, lifestyle questionnaires, and saliva collection for genetic testing, and education and training activities.
Next 1 month: Supervised use of the BIO-STREAMS digital interventions. Participants will use the BIO-STREAMS mobile app under clinical supervision to track their activities and receive personalized health recommendations.
Next 3 months: Unsupervised use of BIO-STREAMS digital interventions and using the app independently.
Final check-up: Saliva samples (for genetic testing), body measurements, and questionnaires about user experience, usability, acceptance, health and food literacy, and trust and health habits and well-being.
What are the possible benefits and risks of participating?
Benefits: Participants will gain access to personalized health recommendations and digital tools designed to promote healthy living. They will also contribute to important research that may help prevent childhood obesity for future generations.
Risks: The study involves minimal risks. Collection of saliva samples may cause slight discomfort. There is also a small risk related to data privacy, but strict security measures are in place to protect all personal information. Psychological support will be available if needed, and participants can withdraw at any time.
Where is the study run from?
The study is run from clinical sites across six European countries:
University Medical Centre Maribor (Slovenia)
National and Kapodistrian University of Athens (Greece)
Karolinska Institute (Sweden)
Blocks Health and Social Care EOOD (Bulgaria)
Hospital Universitari Vall d'Hebron (Spain)
Centre Hospitalier Universitaire de Liège (Belgium)
Penteli General Children's Hospital (Greece)
When is the study starting and how long is it expected to run for?
September 2024 to February 2027. Co-creation workshops will begin in 2024. The main intervention study is planned to start in early 2025, with the first participants completing the study by late 2025. The final results are expected by early 2026.
Who is funding the study?
The European Union's HORIZON EUROPE HEALTH
Who is the main contact?
Dr Izidor Mlakar, izidor.mlakar@um.si
Contact information
Public, Scientific
Koroška cesta 46
Maribor
2000
Slovenia
 ORCID ID |
0000-0002-4910-1879 |
|---|---|
| Phone | +386 2 220 7267 |
| izidor.mlakar@um.si |
Principal investigator
Ljubljanska 5
Maribor
2000
Slovenia
| Phone | +386 (0)2 321 1000 |
|---|---|
| Martin.Bigec@ukc.mb.si |
Principal investigator
Thivon and Levadias
Athens
11527
Greece
| Phone | +302132013384 |
|---|---|
| evangelia.charmandari@googlemail.com |
Principal investigator
Alfred Nobels allé 8
Stockholm
14152
Sweden
| ORCID ID |
0000-0003-2806-6186 |
|---|---|
| billy.langlet@ki.se |
Principal investigator
1,Konstantin Pomianov str
Sofia
1415
Bulgaria
| Phone | +359888061383 |
|---|---|
| savova.radka@gmail.com |
Principal investigator
Pg. de la Vall d'Hebron, 129
Barcelona
08035
Spain
| Phone | +34 934 89 30 00 |
|---|---|
| andreea.ciudin@vallhebron.cat |
Principal investigator
Avenue de l'Hôpital, 1
Liege
4000
Belgium
| Phone | +32(0)43230000 |
|---|---|
| cgernay@chuliege.be |
Principal investigator
Ippokratous 8
Penteli
15236
Greece
| Phone | +302132052507 |
|---|---|
| info@biostreams-penteli.eu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed-methods non-randomized study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | BIO-STREAMS: a multi-center mixed method trial evaluating personalized digital interventions for prevention of childhood and adolescent obesity based on genetic, epigenetic, and behavioral factors |
| Study acronym | PERSOM |
| Study objectives | H1: The personalized lifestyle modification interventions delivered through the BIO-STREAMS platform will identify novel biological pathways that enhance the efficacy of preventive behaviors among children and adolescents, thereby contributing to improved health outcomes. H2: BIO-STREAMS: A Multi-Center Mixed Method Trial Evaluating Personalized Digital Interventions for Prevention of Childhood and Adolescent Obesity Based on Genetic, Epigenetic, and Behavioral Factors |
| Ethics approval(s) |
1. Approved 16/10/2024, Komisija Republike Slovenije za medcinsko etiko (Štefanova ulica 5, Ljubljana, 2000, Slovenia; +386 (0)14786906; kme.mz@gov.si), ref: 0120-410/2024-2711-3 2. Approved 27/09/2024, Scinetific Council of Athens Children's General Hosptial "Agia Sofia" (Thivon & Papadiamantopoulou, Athens, 11522, Greece; +30 (0)2132013099; a.tsola@paidon-agiasofia.gr), ref: 23716/27.09.2024 3. Submitted 03/03/2025, Ethics Committee of the Specialized Hospital for Rehabilitation and Long-Term Treatment BLOCKS (SBRPL BLOCKS) (Konstantin Pomyanov St., 1, Sofia, 1415, Bulgaria; +359 (0)888061383; research@blocks.care), ref: BLOCKS-2024-19 4. Not yet submitted, Ethics Committee of the CHU Liege (707) (Avenue de l'Hôpital, 1, Liege, 4000, Belgium; +32 (0) 4.323.00.00; ethique@chuliege.be), ref: To be submittted when approved 5. Approved 13/11/2024, Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2024-05917-01 6. Approved 19/09/2024, Scientific Council of Children's Hospital PENTELI (Hippocrates 8, Penteli, 15236, Greece; +30 (0)213-2052315; sgnpp@paidon-pentelis.gr), ref: 10917/19-9-24 7. Submitted 10/12/2024, Clinical Research Ethics Committee of University Hospital VALL D'HEBRON (Paseo de la Vall d'Hebron, 119-129, Barcelona, 08035, Spain; +34 (0)934 89 30 00; ceic@vhir.org), ref: To be submittted when approved |
| Health condition(s) or problem(s) studied | The study compared children without overweight/obesity, those with overweight/obesity and normal metabolic parameters, and those with overweight/obesity and metabolic abnormalities. |
| Intervention | 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 within-subject design where participants are stratified into three groups: Children without overweight/obesity (CWO) Children with overweight/obesity but normal metabolism (CONM) Children with overweight/obesity and metabolic health issues (e.g., high blood sugar or cholesterol) (COMA) The participants undergo a 6-month intervention with personalized lifestyle recommendations delivered through digital tools, without randomization or masking, and no control group in the traditional sense, but rather a comparison across different participant groups. Co-creation workshops with an open discussion on the topics related to the aims of the co-creation led by moderators. Group activity with similarly aged 6-8 children in each group: minimum 144 participants in total, from different age groups (minimum 36 participants per age-group in total; (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 the digital solutions (The ActiveHealth app, Serious Games, Micro-moments, Open Toolkit services, Risk Assessment Tool and Recommendation Engine) in a prospective study, where the user experience (engagement, acceptance, adherence) will be assessed, as well as the impact of the solution on targeted health outcomes. To this end, participants will then enter a 4-month intervention program supported by an internet-based application where individual-centric and family-centric recommendations, based on micro-moments, for physical activity and changes in dietary intake will be generated using the BIO-STREAMS EU Childhood Obesity Platform recommendation toolsets. The intervention will have 6 measurement points, with 2 times saliva sampling and centralized analysis (saliva-centrally) and 1-time blood (in case no data not older than 1 year is already available). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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. |
| Completion date | 28/02/2027 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1050 |
| Key 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 |
| Key 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,…) |
| Date of first enrolment | 31/05/2025 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- Belgium
- Bulgaria
- Greece
- Slovenia
- Spain
- Sweden
Study participating centres
Maribor
2000
Slovenia
Athens
11527
Greece
Stockholm
141 52
Sweden
Sofia
1415
Bulgaria
Barcelona
08035
Spain
Liege
4000
Belgium
Penteli
15236
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Izidor Mlakar (Clinical Coordinator of BIO-STREAMS Studies, izidor.mlakar@um.si). Only anonymized data and synthetic data will be shared with 3rd party researchers outside the consortium under the Federated Data Storage paradigm (i.e. the BIO-STREAMS Node Bundle), hosted by the BIO-STREAMS Information Management System. Personal data collected for the purpose of this clinical investigation will be kept in the non-publicly available repository, up to 10 years after the study ends or until the data subjects (or their legal guardians) initiate their right to be forgotten or withdraw their consent. • The type of data that will be shared anonymized data (e.g. cohort data) and synthetic data • Timing for availability Not before April 2027 • Whether consent from participants was required and obtained Written Informed consent was required and obtained • Comments on data anonymization Data shared under the Federated Data Storage paradigm (i.e. the BIO-STREAMS Node Bundle) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/06/2025: Internal review.
12/03/2025: Study's existence confirmed by the Commission of the Republic of Slovenia for Medical Ethics (Komisija Republike Slovenije za medcinsko etiko).
