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

Summary

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.

Conditions

• Type 2 Diabetes
• PreDiabetes
• Hypertension
• Obesity & Overweight

Interventions

BEHAVIORAL

Standard care

Participants will receive standard care, including lifestyle recommendations.

BEHAVIORAL

mHealth self-management intervention

A 24-month mHealth self-management intervention combining structured face-to-face counselling (n=5-7) with continuous digital support. Counselling follows the Transtheoretical Model, incorporating self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement via shared decision-making. Three additional intensive sessions are delivered in weeks 2, 4, and 8, followed by ongoing support through four interoperable digital tools, supporting nutrition counselling, clinical monitoring, blood glucose and blood pressure self-monitoring, and medication adherence. Delivery is by multidisciplinary primary care teams using standardised operating procedures. Intervention intensity and visit schedules differ by metabolic subgroup (intermediate hyperglycaemia vs T2DM).

Sponsors & Collaborators

• Medical University of Varna

  collaborator OTHER

• Centre for Research and Technology Hellas

  collaborator OTHER

• University of Medicine, Tirana

  collaborator OTHER

• La Trobe University

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• University Ghent

  collaborator OTHER

• Universidad de Zaragoza

  collaborator OTHER

• PRIVANOVA SAS

  collaborator UNKNOWN

• Monash University

  collaborator OTHER

• METEDA SRL

  collaborator UNKNOWN

• Baker Heart and Diabetes Institute

  collaborator OTHER

• Sant'Anna School of Advanced Studies

  collaborator UNKNOWN

• International Diabetes Federation

  collaborator OTHER

• STICHTING INTERNATIONAL FOUNDATION FORINTEGRATED CARE

  collaborator UNKNOWN

• EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME (Project Number: 945246)

  collaborator UNKNOWN

• Harokopio University

  lead OTHER

Principal Investigators

• Yannis Manios, Professor · Harokopio University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2025-12-20

Completion

2025-12-20

Countries

• Albania
• Bulgaria
• Greece
• Spain

Study Locations