A Health Coach-Led Digital Lifestyle Intervention (HEALDI)

Starting soon · Not applicable

Conditions studied: Myocardial Fibrosis, Left Ventricle Hypertrophy, Hypertensive Disease, Hypertension

In brief

Aim: To evaluate the effectiveness of an artificial intelligence (AI)-assisted 12-month Health Coach-Led Digital Lifestyle Intervention (HEALDI) versus control on diffuse myocardial fibrosis and ambulatory blood pressure in individuals with hypertensive heart disease (HHD), with secondary outcomes including multi-organ health parameters, health behaviours, social support, psychological health, and health-related quality of life. Background: The global prevalence of hypertensive heart disease (HHD) has increased approximately 1.5-fold, from 7.82 million cases in 1990 to 12.50 million in 2021, and it is now the second leading cause of heart failure worldwide. In HHD, chronic pressure overload drives fibroblast activation and interstitial collagen deposition, leading to diffuse myocardial fibrosis which is associated with cardiac dysfunction, arrhythmias, impaired coronary flow reserve, and an increased risk of sudden cardiac death and heart failure. Although diffuse myocardial fibrosis is potentially reversible, no approved anti-fibrotic pharmacological therapy currently exists. Furthermore, there is limited evidence evaluating the effectiveness of lifestyle interventions, particularly aerobic exercise, in reversing diffuse myocardial fibrosis. Design: A parallel, single-blinded two-arm randomised controlled trial. Method: This study is a randomised controlled trial with repeated measures, recruiting 200 physically inactive individuals with HHD from the community, including participants from Project RESET, a community-based cohort study in Singapore. Participants will be randomly allocated to either the intervention or control group. Participants in the intervention group will receive the 12-month HEALDI intervention, which includes the HEALDI mobile application, wearable device, and remote health coaching. Participants in the control group will receive a wearable device and a basic mobile application without intervention features, used solely for data collection. Data will be collected at baseline (upon randomisation) and at 6, 12 and 24 months. A process evaluation will be conducted using intervention engagement data. In addition, semi-structured interviews with participants and health coaches will explore perceptions of the intervention and behaviour change. A within-trial economic evaluation, from both healthcare system and societal perspectives, will be performed to assess cost-effectiveness. Significance: This study will generate insights into the role of lifestyle modification as a complementary, non-pharmacological strategy alongside pharmacotherapy to halt or slow HHD progression, improving long-term cardiovascular outcomes.

Key facts

Study ID: NCT07530562
Run by: National University of Singapore
People needed: 200
Starts: 2026-04-01
Expected to finish: 2028-06-01
Last updated by the study team: 2026-04-15

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Left ventricular hypertrophy on cardiovascular magnetic resonance based on local age and sex specific criteria
Age 40-70 years old
Has internet access
Owns and uses a smartphone daily
Able to converse and comprehend the English or Chinese language

You may not qualify if…

History of major cardiovascular events (MACE), which is defined as coronary heart disease death, non-fatal myocardial infarction, stroke
Diagnosed with secondary causes of hypertension (E.g., renal causes - renal artery stenosis, chronic renal failure; endocrine causes- pheochromocytoma, Cushing's syndrome, hyperthyroidism; cardiac causes - coarctation of the aorta)
Diagnosed with significant coronary artery disease with previous percutaneous intervention or coronary artery bypass surgeries
Diagnosed with cardiac arrhythmias such as atrial fibrillation and frequent premature ventricular contractions
Diagnosed with inherited/acquired cardiomyopathies (E.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)
Diagnosed with infiltrative disease (E.g., cardiac amyloid, cardiac sarcoid)
Contraindications to Brain and Cardiac Magnetic Resonance or gadolinium contrast (E.g., renal failure- eGFR <30ml/min/m2 or documented contrast allergy; implantable devices such as cardiac pacemakers, brain aneurysms or clips, metal implants (including braces), foreign bodies in the eye; claustrophobia; end organ failure; women who are pregnant or breast-feeding)
Any pre-existing medical conditions or disabilities that limits their participation in lifestyle interventions (E.g., Dementia)
Individuals who have achieved the Singapore physical activity guideline of 150 minutes of moderate intensity exercise or 75 minutes of vigorous intensity exercise per week or an equivalent combination per week
Limited life expectancy of less than 12 months
Participating in other research projects involving behavioural therapy or changes related to physical activity

Full record on ClinicalTrials.gov

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