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Completed NCT05648383

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

Conditions: Type 2 Diabetes, PreDiabetes, Hypertension, Obesity & Overweight

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1215
Sponsor: Harokopio University

Location: Universiteti i Mjekësisë Tirana Rruga E Dibrës

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05648383). StuddyBuddy aggregates publicly available trial information.