Risk of developing cardiovascular and metabolic disease in children and adolescents based on their lifestyle Other
Conditions
Interventions
The intervention will be implemented during one school year (i.e., about 6-9 months) and involves an e-Health tool that consists of two parts: 1) a web-based application intended for healthcare profes
2) a mobile application for families or adolescents (depending on the study site). After recruitment, adolescents (or their parents in the case of younger children) will download the SmartCHANGE mobil
participants with a low-risk level will be encouraged to keep using the application on their own. For the medium and high-risk participants, at the first visit to the healthcare professional’s office,
Sponsors
Jožef Stefan Institute
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: Participants from Portugal: 1. Family physician or paediatrician willing to participate 2. Children aged 6-10 years under the care of a family physician or paediatrician Participants from Slovenia: 1. A functional multidisciplinary team at the community centre 2. Multidisciplinary team members are registered users of the MySLOfit app that supports access to data obtained in SLOfit – Slovenian physical fitness surveillance system in the schooling period 3. At least 50 children aged 6-10 years under the care of primary members of the team. Participants from Nederlands: 1. Aged 11-14 years 2. Attending schools connected to the participating child public health care facilities Updated 20/12/2024: Participants from Finland: 1. School nurses willing to participate 2. Children aged 11 and 14 years from schools under the care of school nurses Updated 03/09/2025: Participants from Taiwan: 1. Family physician or paediatrician willing to participate 2. Children aged 13-14 years under the care of a family physician or paediatrician Previous inclusion criteria: Participants from Finland: 1. Family physician or paediatrician willing to participate 2. Children aged 6-10 years under the care of a family physician or paediatrician Participants from Taiwan: 1. Family physician or paediatrician willing to participate 2. Children aged 6-10 years under the care of a family physician or paediatrician
Exclusion criteria
Exclusion criteria: Simultaneous participation in another study that might affect the findings of both studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following seven aspects of feasibility of SmartCHANGE applications across different settings will be assessed at 9 months after baseline: 1. Acceptability measured using interviews inquiring about satisfaction with the overall intervention, perceived appropriateness and fit within the daily schedule or clinical routine 2. Demand will be measured through: 2.1. Uptake (number of participants approached, consented, and completed) 2.2. Adherence and actual use assessed via application use data 2.3. Likelihood of continued use, perceived demand, and perceived positive or negative effects on other aspects of life/work assessed via interviews 3. Implementation will be measured via interviews inquiring about how the intervention was implemented (e.g., amount of time used, amount of conversations with child), the success or failure of execution of different elements of the intervention 4. Practicality will be measured via interviews inquiring about factors affecting implementation ease or difficulty, efficiency and quality of implementation and the ability of participants to perform intervention activities 5. Adaptation, efficiency and quality of implementation comparison between five clinical settings 6. Integration will be measured via interviews inquiring about the ease of integration into the protocols and procedures within the specific healthcare setting, perceived fit with existing infrastructure and perceived costs of full integration 7. Expansion will be measured via interviews inquiring about the perceived potential for expansion and perceived barriers to expansion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Usability and user satisfaction assessed 9 months after baseline 2. User impressions and feedback on their experience with the two applications will be gathered using focus group interviews with families and adolescents and semi-structured interviews with healthcare professionals. Unmoderated usability testing scenarios will be used. 3. Explainability of the AI-based models, assessed 9 months after baseline only in healthcare professionals using semi-structured interviews accompanied by interactive tasks. This group of outcomes will include: 3.1. Transparency 3.2. Scrutability 3.3 Trust 3.4. Effectiveness 3.5. Satisfaction 4. Lifestyle behaviours, measured at baseline and 4- and 9-months post baseline: 4.1. Physical activity, activity-related energy expenditure, and duration of moderate-to-vigorous physical activity during one week measured by Garmin Vivosmart 5 fitness tracker 4.2. Sleep, duration of nocturnal sleep during one week, measured by Garmin Vivosmart 5 fitness tracker 4.3. Diet, measured by the Mediterranean Eating Pattern for Americans (MEPA) Questionnaire 4.4. Screen time, measured by self-report on recreational screen use during one typical day 5. Cardiometabolic risk and biological risk factors for chronic non-communicable disease, assessed at baseline and 4-, and 9-months post baseline: 5.1. Blood pressure, measured using standard equipment and procedures in clinical settings involved in the study 5.2. Body Mass Index – calculated from weight and height, measured using standard procedures 5.3. Resting heart rate, measured by Garmin Vivosmart 5 fitness tracker and averaged over one week 5.4. Heart rate variability, measured by Garmin Vivosmart 5 fitness tracker and averaged over one week 5.5. Risk of cardiometabolic disease, measured at baseline and 9 months post-baseline, calculated by the custom-made SmartCHANGE risk calculator | — |
Countries
Finland, Netherlands, Portugal, Slovenia, Taiwan
Contacts
Public ContactMaroje Soric
Outcome results
None listed