A Health Coach-Led Digital Lifestyle Intervention (HEALDI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorNational University of Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HEALDI Intervention
Other interventionProposed Mobile application features include: educational content on HHD and lifestyle behaviours (e.g., physical activity, nutrition, stress, sleep), AI-driven exercise recommendations (frequency, intensity, duration, and type), reviewed and approved by health coaches prior to delivery, Health logging (e.g., blood pressure, medication), Personalised dashboard displaying wearable and self-reported data, Goal setting and progress tracking (short- and long-term), Behavioural nudges (AI-driven and rule-based), Messaging function to facilitate communication with health coaches. Health coaching session involve personalised goal setting and review.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: HEALDI Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Regression of diffuse myocardial fibrosis
Change in indexed interstitial volume assessed by cardiovascular magnetic resonance
Time frame
Baseline and 12 months upon randomisationSecondary outcomes
1
Blood pressure
Change in the average 24-hour systolic and diastolic blood pressure
Time frame
Baseline and 12 months upon randomisation2
Left ventricular function
Assessed using cardiovascular magnetic resonance
Time frame
Baseline and 12 months upon randomisation.3
Left ventricular mass
Assessed using cardiovascular magnetic resonance for changes from baseline, indexed to body surface area (g/m2).
Time frame
Baseline and 12 months upon randomisation.4
Left ventricular volume
Assessed using cardiovascular magnetic resonance.
Time frame
Baseline and 12 months upon randomisation.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Singapore
Lead sponsor
National Heart Centre Singapore
Collaborator
Source ClinicalTrials.gov
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