This study investigates the potential of digital health technologies (DHTs), such as wearable devices and smartphones, to complement traditional submaximal functional capacity tests, such as the 6 min walk test (6MWT) and the timed up and go test (TUG). While these traditional tests are widely used due to their simplicity and relevance to daily living activities, they have limitations, including infrequent administration and the need for clinical observation. DHT offers continuous, real-world monitoring, which may accurately reflect patients’ health status and effectively inform clinical decisions. However, there is a need to establish the validity of the data and metrics computed through DHT and understand patient perspectives on using such technology.

This is an observational pilot study (Synergy Digital Health study) that aims at linking wearable data with traditional test outcomes and assessing participants’ acceptance and usage of such DHT. A cohort of 30 cardiovascular patients from Oxford University Hospitals, UK, and 30 community-dwelling elderly people from social centres in Helsingborg, Sweden, will use wearable devices for 2 months in free-living conditions, they will fill out technology acceptance questionnaires (AQs), have baseline assessments and perform physical tests such as the 6MWT and TUG using the Mobistudy smartphone app. Subgroups will participate in codesign workshops to identify experience-based design recommendations for the technology. Quantitative and qualitative methods will be adopted to analyse the collected data.

The study protocol received ethical approval in Sweden from the Etikprövningsmyndigheten (2024-04886-01) and in the UK from the National Health Service (NHS) Research Ethics Committees (Iras project ID: 340870), in accordance with local regulations. All participants are asked for written informed consent. The results of the study will be shared via scientific journals and conferences.

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

DRKS00030749 (29-09-2023)