The goal of this hybrid type II effectiveness-implementation trial is to evaluate whether an intersectoral, digitally enabled, family-based intervention can prevent and manage type 2 diabetes mellitus (T2DM) and hypertension (HTN) in adults with intermediate hyperglycaemia or T2DM (with or without HTN), and improve growth outcomes in their children, across socioeconomically diverse communities in Albania, Bulgaria, Greece, and Spain.

The main questions it aims to answer are:

• Does the DigiCare4You intervention reduce HbA1c levels in adults with T2DM compared to enhanced standard care?
• Does the DigiCare4You intervention reduce fasting plasma glucose levels in adults with intermediate hyperglycaemia compared to enhanced standard care?
• Does the DigiCare4You intervention improve BMI z-scores in children linked to enrolled parents compared to enhanced standard care?

Researchers will compare the DigiCare4You intervention group to the enhanced standard care group to see if combining structured counselling, digital self-management tools, and school/community reinforcement improves cardiometabolic outcomes in adults and growth outcomes in children beyond standard national guideline-based care.

Participants will:

• Complete a two-stage screening procedure, including a digital risk questionnaire and a clinical assessment, to confirm eligibility
• Attend structured assessment visits at regular intervals over 24 months, including anthropometric, biochemical, and blood pressure measurements
• Receive (intervention group only) three intensive face-to-face counselling sessions in the first eight weeks, followed by ongoing digital self-management support through interoperable mobile health tools
• Be encouraged to adopt healthier lifestyle behaviours as a family unit throughout the study period.

DigiCare4You is an EU-funded (Horizon 2020) hybrid type II effectiveness-implementation study conducted across four European countries: Albania, Bulgaria, Greece, and Spain. The study addresses a critical gap in chronic disease prevention by combining community-based screening with a digitally supported self-management intervention targeting adults at cardiometabolic risk and their families.

Background and rationale Type 2 diabetes mellitus (T2DM) and hypertension (HTN) are among the leading causes of preventable morbidity and mortality in Europe, disproportionately affecting socioeconomically vulnerable populations. Despite their high burden, early detection and sustained management remain inconsistently delivered, particularly among groups with limited engagement in preventive healthcare. DigiCare4You was designed to address this through an equity-focused, scalable model that integrates screening, prevention, and long-term self-management support within existing health and educational infrastructures.

Study design The study uses a cluster-randomised design, with municipalities allocated 1:1 to either the DigiCare4You intervention arm or the enhanced standard care arm. Randomisation at the municipality level was chosen to minimise contamination between participants and to enable delivery through existing local healthcare and school structures.

Screening approach A novel two-stage screening procedure was embedded within existing national child growth monitoring services, using routine interactions between families and health or educational services as entry points to reach parents and caregivers who might otherwise have limited contact with preventive care. Stage 1 involved a digital self-reported risk questionnaire based on the FINDRISC score. Adults scoring ≥10 were referred to Stage 2, which included glycaemic testing, blood pressure measurement, and anthropometric assessment at local healthcare centres. Adults confirmed with intermediate hyperglycaemia or T2DM, with or without HTN, were invited to join the intervention.

Intervention The 24-month intervention combined structured face-to-face counselling with continuous digital self-management support. Counselling was guided by the Transtheoretical Model and incorporated established behaviour change techniques including self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement, delivered through a shared decision-making approach. Three intensive counselling sessions were provided in the first eight weeks, followed by ongoing support through four interoperable digital tools (MetaDieta, MyDiet, MetaClinic, DiaWatch) supporting nutrition counselling, clinical monitoring, and medication adherence. School- and community-based components reinforced healthy behaviours within the broader family environment.

The intervention was delivered by existing multidisciplinary healthcare teams (internists, general practitioners, diabetologists, nurses, and dietitians) within primary care settings, trained using standardised materials and operating procedures. All digital tools are classified as medical devices under EU MDR 2017/745 and were adapted to each national context prior to deployment.

Enhanced standard care Participants in the enhanced standard care arm received structured assessment and care consistent with national clinical guidelines, including regular monitoring visits with anthropometric, biochemical, and blood pressure measurements and feedback, at intervals appropriate to their metabolic status (every 12 months for intermediate hyperglycaemia; every 3-6 months for T2DM).

Evaluation The study simultaneously evaluates clinical effectiveness and implementation outcomes using a mixed-methods approach guided by three complementary frameworks: PRECEDE-PROCEED, RE-AIM, and CFIR. Primary effectiveness outcomes are changes in HbA1c (T2DM subgroup), fasting plasma glucose (intermediate hyperglycaemia subgroup), and BMI z-scores in children. Implementation outcomes include reach, adoption, fidelity, feasibility, and sustainability. Economic evaluation includes cost-effectiveness and budget impact analyses using Markov modelling over a lifetime horizon.

Study structure The project spans five and a half years across three phases: Phase 1 (context analysis, needs assessment, and participatory co-design with stakeholder advisory boards); Phase 2 (intervention implementation and evaluation); and Phase 3 (cost-effectiveness, scalability, and transferability assessment). Findings are intended to inform evidence-based recommendations for scaling the DigiCare4You model across European health systems.

Inclusion Criteria:

• People who have their permanent residence within the prefecture/region of the relevant facility participating in the clinical study.
• People having children at primary and/ or secondary education.
• People who are physically and mentally able to provide their informed consent to participate.
• People with a FINDRISC ≥10
• People with a fasting plasma glucose (FPG) ≥ 100 mg/dL and /or glycated hemoglobin (HbA1c) ≥ 5.7%

Exclusion Criteria:

• People suffering from a health condition where adherence to the intervention will be contraindicated or improbable.
• People unable to express a free and informed consent for medical and/or psychological conditions, mental incapacity.

De-identified individual participant data (IPD) collected throughout the DigiCare4You trial will be shared with consortium partners and may be made available to external researchers upon reasonable request. Shared data will include participant-level clinical, anthropometric, biochemical, and behavioural data collected at baseline, 12 months, and 24 months, as well as implementation-related data. Data will be shared in accordance with the study's Data Management Plan, applicable data protection legislation (EU GDPR), and the ethical approvals granted in each participating country. Requests for access will be reviewed by the study coordination team at Harokopio University of Athens. Further details on data availability, access criteria, and supporting documentation (including data dictionaries and analysis code) will be made available upon publication of the primary results.