A Health Coach-Led Digital Lifestyle Intervention (HEALDI)

NCT07530562 | Not Yet Recruiting

• 2 other identifiers: 2024-3874OFLCG22may-0010
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocardial Fibrosis; Left Ventricle Hypertrophy; Hypertensive Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

• Regression of diffuse myocardial fibrosis

  Change in indexed interstitial volume assessed by cardiovascular magnetic resonance

  Baseline and 12 months upon randomisation

Secondary Outcomes (39)

• Blood pressure

  Baseline and 12 months upon randomisation

• Left ventricular function

  Baseline and 12 months upon randomisation.

• Left ventricular mass

  Baseline and 12 months upon randomisation.

• Left ventricular volume

  Baseline and 12 months upon randomisation.

• Diastolic and systolic function

  Baseline and 12 months (upon randomisation)

Study Arms (2)

HEALDI Intervention Group

EXPERIMENTAL

A 12-month, AI-assisted, health coach-led digital lifestyle intervention where participants will receive a wearable, HEALDI mobile app and remote health coaching sessions.

Other: HEALDI Intervention

Control Group

NO INTERVENTION

Participants will receive a wearable and basic mobile app without intervention features, used solely for data collection.

Interventions

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.

HEALDI Intervention Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National University of Singapore: lead
• National Heart Centre Singapore: collaborator

Related Publications (4)

• Wang K, Deng Y, Xiao H. Exercise and cardiac fibrosis. Current Opinion in Physiology. 2023;31(100630)doi:https://doi.org/10.1016/j.cophys.2022.100630

  BACKGROUND

• González A, López B, Ravassa S, et al. Myocardial Interstitial Fibrosis in Hypertensive Heart Disease: From Mechanisms to Clinical Management. Hypertension. Feb 2024;81(2):218-228. doi:10.1161/hypertensionaha.123.21708

  BACKGROUND

• Lawson CA, Zaccardi F, Squire I, Okhai H, Davies M, Huang W, Mamas M, Lam CSP, Khunti K, Kadam UT. Risk Factors for Heart Failure: 20-Year Population-Based Trends by Sex, Socioeconomic Status, and Ethnicity. Circ Heart Fail. 2020 Feb;13(2):e006472. doi: 10.1161/CIRCHEARTFAILURE.119.006472. Epub 2020 Feb 14.

  PMID: 32059630 BACKGROUND

• Dai H, Bragazzi NL, Younis A, Zhong W, Liu X, Wu J, Grossman E. Worldwide Trends in Prevalence, Mortality, and Disability-Adjusted Life Years for Hypertensive Heart Disease From 1990 to 2017. Hypertension. 2021 Apr;77(4):1223-1233. doi: 10.1161/HYPERTENSIONAHA.120.16483. Epub 2021 Feb 15.

  PMID: 33583201 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wenru Wang, PhD

CONTACT

(65) 66011761; nurww@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will remain blinded to group allocation. Outcome assessors, including research assistants administering questionnaires and technicians performing study procedures, will be blinded to participants' assigned groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04