Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 1215
• From 1 Oct 2022 to the primary completion date, 20 Dec 2025
• 4 sites in 4 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

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