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NCT Number: NCT07530562

A Health Coach-Led Digital Lifestyle Intervention (HEALDI)

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.

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Key information

Conditions

Myocardial Fibrosis Cardiovascular Diseases Hypertension Hypertensive Disease Left Ventricle Hypertrophy Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Specific Study Aims

  • To compare the effectiveness of HEALDI on change in diffuse myocardial fibrosis, ambulatory blood pressure, with secondary outcomes including multi-organ clinical parameters (e.g. blood tests, liver and brain imaging) and patient-reported outcomes (e.g. physical activity, dietary practices, perceived stress, sleep quality, medication adherence, social support, psychological health, and health-related quality of life).
  • Examine the cost-effectiveness of HEALDI intervention.
  • Explore the perceptions of the individuals with HHD and health coaches regarding HEALDI.

Hypotheses

It is hypothesised that participants who received the HEALDI intervention, compared to the control group will have:

  • Greater regression in diffuse myocardial fibrosis;
  • Greater improvement in ambulatory blood pressure;
  • Improved multi-organ clinical paramaters;
  • Greater adoption and sustained adherence to health behaviours;
  • Better quality of life;
  • Lower cost to participants and hospitals.

HEALDI Intervention The HEALDI intervention is a 12-month, AI-assisted, health coach-led digital lifestyle intervention comprising a wearable device, HEALDI mobile application, health coach web portal, and administrative web portal. The system functions as an integrated platform to facilitate interaction between participants and health coaches, supporting personalised lifestyle modification.

Participants will access the HEALDI mobile application via their personal smartphones and will be provided with a wearable device that continuously collects activity and physiological data. These data, together with participant-entered health metrics (e.g., blood pressure, medication), will be synchronised to a secure cloud server and made available on the health coach portal to inform coaching sessions, including goal setting and progress review.

Certified health coaches will deliver 30-45-minute remote coaching sessions over 12 months: weekly during the first month, biweekly for the subsequent 5 months, and monthly for the remaining 6 months.

Data Analysis Data will be analysed using IBM SPSS Statistics Version 29.0, with two-tailed p<0.05 indicating statistical significance. Analyses will follow the intention-to-treat principle. Baseline categorical variables will be compared using Chi-squared or Fisher's exact tests, and continuous variables using independent t-tests or Mann-Whitney U tests, depending on normality. Linear mixed models will assess repeated continuous outcomes, and generalized estimating equations (GEE) will be used for ordinal outcomes. Descriptive analyses will summarise utilisation of the mobile app, wearable adherence, and coaching engagement.

Qualitative interviews will be audio-recorded, transcribed, and analysed thematically using Braun and Clarke's six-step framework. Two independent coders will familiarise themselves with the data, generate initial codes and iteratively refine them through discussion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HEALDI Intervention

Other

Proposed 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.

Primary outcomes

  1. Regression of diffuse myocardial fibrosis

    Time frame: Baseline and 12 months upon randomisation

    Change in indexed interstitial volume assessed by cardiovascular magnetic resonance

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline and 12 months upon randomisation

    Change in the average 24-hour systolic and diastolic blood pressure

  2. Left ventricular function

    Time frame: Baseline and 12 months upon randomisation.

    Assessed using cardiovascular magnetic resonance

  3. Left ventricular mass

    Time frame: Baseline and 12 months upon randomisation.

    Assessed using cardiovascular magnetic resonance for changes from baseline, indexed to body surface area (g/m2).

  4. Left ventricular volume

    Time frame: Baseline and 12 months upon randomisation.

    Assessed using cardiovascular magnetic resonance.

  5. Diastolic and systolic function

    Time frame: Baseline and 12 months (upon randomisation)

    Assessed by echocardiogram

  6. Valvular function

    Time frame: Baseline and 12 months (upon randomisation).

    Assessed by echocardiogram

  7. Heart function

    Time frame: Baseline and 12 months upon randomisation

    Assessed by electrocardiogram

  8. First occurrence of cardiovascular event

    Time frame: 2 years

    Heart failure, Myocardial Infarction, Strokes and Death

  9. Markers of liver fat, inflammation and stiffness

    Time frame: Baseline, 12 months and 24 months upon randomisation

    Assessed by liver fibroscan

  10. Markers of liver fat, inflammation and stiffness

    Time frame: Baseline and 12 months upon randomisation.

    Assessed by liver magnetic resonance

  11. Brain structure

    Time frame: Baseline, 12 months and 24 months upon randomisation.

    Assessed using brain magnetic resonance to characterise brain microstructure and extracellular space.

  12. Cognitive function

    Time frame: Baseline and 12 months upon randomisation.

    Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA), on a 0-30 scoring scale.

    Thresholds are:

    Severe cognitive impairment: 0-9 Moderate cognitive impairment: 10-17 Mild cognitive impairment: 18-25 Normal cognitive performance: 26-30

  13. Cardiac and inflammatory markers

    Time frame: Baseline, 12 months and 24 months

    Cardiac and inflammatory markers, including but not limited to C-reactive Protein and Cardiac Troponins, will be assessed by blood specimen.

  14. Circulating biomarkers of inflammation and fibrosis

    Time frame: Baseline and 12 months upon randomisation.

    Assessed using blood specimen, inclusive of but not limited to, PICP (procollagen type I carboxy-terminal propeptide) and PIINP ( procollagen type III amino-terminal propeptide).

  15. Liver function tests

    Time frame: Baseline, 12 months and 24 months from randomisation

    Assessed by blood specimen

  16. Lipid profile

    Time frame: Baseline, 12 months and 24 months upon randomisation

    Assessed by blood specimen

  17. Renal function markers

    Time frame: Baseline, 12 months and 24 months from randomisation

    Renal function markers, including but not limited to creatinine, will be assessed by blood specimen

  18. Glycemic control

    Time frame: Baseline, 12 months and 24 months upon randomisation.

    Assessed by fasting blood specimen

  19. Body Mass Index

    Time frame: Baseline, 12 months and 24 months upon randomisation.

    Change in Body Mass Index (BMI) will be assessed using weight (kilograms) and height (meters) combined to report BMI in kg/m^2.

  20. Body composition: Body fat

    Time frame: Baseline and 12 months upon randomisation.

    Body fat (% or kg) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA)

  21. Body composition: Muscle Mass

    Time frame: Baseline and 12 months upon randomisation.

    Muscle mass (kg) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA).

  22. Body composition: Total body water

    Time frame: Baseline and 12 months upon randomisation.

    Total body water (% or Litre) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA).

  23. Waist Circumference

    Time frame: Baseline, 12 months and 24 months upon randomisation.

    Change in waist circumference

  24. Energy expenditure

    Time frame: Baseline and 12 months upon randomisation.

    Assessed by whole body calorimetry

  25. Depressive symptoms

    Time frame: Baseline, 6 months, 12 months and 24 months upon enrolment.

    Change in depressive symptoms will be assessed by the Patient Health Questionnaire-9 (PHQ-9), on a scale of 0-27.

    The following PHQ-9 ranges will be used:

    Minimal: 0 - 4 Mild: 5 - 9 Moderate: 10 - 14 Moderately severe: 15 - 19 Severe: 20 - 27

  26. Anxiety symptoms

    Time frame: Baseline, 6 months, 12 months and 24 months upon enrolment.

    Change in anxiety symptoms will be assessed by the Generalized Anxiety Disorder-7 (GAD-7), on a scale of 0-21.

    The following ranges will be used:

    None/minimal: 0 - 4 Mild: 5 - 9 Moderate: 10 - 14 Severe: 15 - 21

  27. Health Behaviour: Physical Activity (Wearable)

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in physical activity-related wearable data such as accelerometery.

  28. Health Behaviour: Physical Activity (IPAQ-SF)

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in physical activity behaviour will be assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to serve as a recall estimate of time spent performing physical activity (moderate or vigorous) and inactivity (sitting).

    The 7-items include:

    • Vigorous activity (days)
    • Vigorous activity (minutes per day)
    • Moderate activity (days)
    • Moderate activity (minutes per day)
    • Walking (days)
    • Walking (minutes per day)
    • Sitting (days)

  29. Health Behaviour: Physical Activity (MPAM-R)

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in physical activity behaviour will be assessed by the Motives for Physical Activities Measure-Revised (MPAM-R), consisting of 30-items, each on a 7-point Likert scale (1 = Not at all true for me; 7 = Very true for me), for a total score ranging between 30 - 210. A higher score will indicate higher motivation, while a lower score will indicate lower motivation.

  30. Health Behaviour: Physical Activity (Stage of Change for Physical Activity Questionnaire)

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in physical activity behaviour will be assessed by the Stage of Change for Physical Activity Questionnaire. The scale consists of 4-items designed to categorise individuals into the five stages of change: pre-contemplation, contemplation, preparation, action, maintenance, based on the Stages of Motivational Readiness for Change Model.

  31. Health Behaviour: Sleep Quality and Duration

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in Sleep Quality and Duration will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and wearable-derived metrics.

    The scale consists of 19-items across seven components: (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction, (5) sleep efficiency, (6) sleep quality, and (7) sleep medication usage. Each component will yield a score from 0 - 3, and will be tallied to yield a score from 0 - 21, with higher scores indicating worse sleep quality.

    Good sleep quality: 0 - 5 Poor sleep quality: 6 - 21

  32. Health Behaviour: Sleep (Wearable)

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation

    Change in sleep-related wearable data

  33. Health Behaviour: Perceived Stress

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10).

    The scale consists of 10 items rated on a 5-point Likert scale (0 - 4, 0 = Never; 4 = Very often), totalling a score of 40.

    The following score range will be used:

    Low stress: 0 - 13 Moderate stress: 14 - 26 High stress: 27 - 40

  34. Health Behaviour: Social Support

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in social support scores will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). It consists of 12-items on a 7-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree), for a maximum possible score of 84. A higher score will indicate higher perceived social support.

  35. Health Behaviour: Medication Adherence

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in medication adherence will be assessed using the Medication Adherence Report Scale (MARS).

    The scale consists of 5-items on a 5-point Likert scale ranging from 1 (never) to 5 (always), with total scores ranging between 5 - 25. Higher scores indicate higher medication adherence.

  36. Health Behaviour: Dietary Behaviour

    Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.

    Change in dietary behaviour will be assessed by the Health Promotion Board Singapore Dietary Questionnaire published in the 2010 National Nutrition Survey.

    The scale consists of 8 items assessing the consumption frequency of fruits and vegetables, wholemeal products, sweetened drinks and food bought from eateries.

  37. Health-related quality of life

    Time frame: Baseline, 6 months, 12 months, 24 months from enrolment.

    Change in health-related quality of life will be assessed using the EQ-5D-5L. The EQ-5D-5L questionnaire will be used to evaluate the health-related quality of life of an individual to derive a 5-digit health profile code (e.g. 11211) and utility score (0 = worse than death; 1 = full health).

  38. Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI)

    Time frame: 6 months, 12 months and 24 months upon randomisation.

    Work Productivity and Activity Impairment Questionnaire: General Health V2.0 will be used to assess absenteeism, presenteeism, and work productivity loss.

    Activity impairment will be measured on a 0-10 scale, with 0 representing no problems and 10 representing severe problems. Total work impairment will be multiplied by the hourly wage to derive the valuation. This will make up part of indirect costs, which will be used for cost effectiveness analysis.

  39. Cost-Effectiveness Analysis (CEA)

    Time frame: 6 months, 12 months and 24 months upon randomisation.

    Cost effectiveness Analysis (CEA) will be assessed via the incremental cost effectiveness ratio (ICER).

    Below details the steps required for conducting CEA:

    • Direct costs will adopt a healthcare system perspective, while indirect costs will be from a societal perspective.
    • Quality-adjusted life years (QALY) will be derived from a cost-survey analysis (direct costs: healthcare resources used will be valued using Singapore-specific unit costs; indirect costs: WPAI questionnaire and informal healthcare costs) and EQ-5D-5L (Singapore-specific value set).
    • ICER will be derived from the difference in mean costs divided by the difference in QALY between the intervention and the control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenru Wang, PhD

CONTACT

[email protected]

(65) 66011761

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National Heart Centre Singapore

Registry information

Official study title

A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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