Advancing Precision Medicine for Cardiovascular Disease and Diabetes in Asian Populations: Digital Intervention Cohort

NCT07728799 | Not Yet Recruiting

• 1 other identifier: NUS-IRB-2025-817
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching aim is to improve cardiometabolic health and promote healthy ageing by supporting adults to adopt favourable lifestyle patterns identified through our observational research. The trial will recruit n=600 to be involved in Phase I (referred to as the "Optimisation Phase") of a two-phase project (Phase II trial registration will be submitted separately). All participants will complete a baseline study visit where, after consent taking, will complete a baseline questionnaire, receive a smartwatch each and additional wearables if applicable, and download the study app for the receiving and testing of interventions and completion of short form surveys. Participants will be involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months. Consenting participants may also be contacted to participate in interviews to be involved in the co-design of interventions, or to provide insights to the feasibility and process evaluation of the trial.

Conditions

Physical Activity; Diet Quality; Sleep; Cardiometabolic Health; Digital Intervention

Keywords

smartphone; smartwatch; ecological momentary assessment; EMA; ecological momentary intervention; EMI; microrandomised trial; mHealth; digital health; intervention

Outcome Measures

Primary Outcomes (3)

• Number of participants having sufficient physical activity

  Based on self-report and devices

  At baseline, and every 5 weeks, up to 52 weeks from joining the study

• Number of participants having sufficient sleep

  Based on self-report and devices

  At baseline, and every 5 weeks, up to 52 weeks from joining the study

• Number of participants meeting dietary guidelines

  Based on self-report

  At baseline, and every 5 weeks, up to 52 weeks from joining the study

Secondary Outcomes (1)

• Glycaemic response

  Up to 3 assessments in total, each assessment lasting 2 weeks, with all assessments completed within 52 weeks from joining the study

Study Arms (4)

Pure Control Arm

NO INTERVENTION

Participants receive the control (no intervention) version for both factors (Factor A control + Factor B control)

Active/Control Arm

EXPERIMENTAL

e.g., in a physical activity (Factor A) x diet (Factor B) (2 x 2) factor, participants in this arm received only the physical activity intervention

Behavioral: Lifestyle intervention targeting physical activity, sleep, and diet

Control/Active Arm

EXPERIMENTAL

e.g., in a physical activity (Factor A) x diet (Factor B) (2 x 2) factor, participants in this arm received only the diet intervention

Behavioral: Lifestyle intervention targeting physical activity, sleep, and diet

Active/Active arm

EXPERIMENTAL

e.g., in a physical activity (Factor A) x diet (Factor B) (2 x 2) factor, participants in this arm received both the physical activity and diet intervention

Behavioral: Lifestyle intervention targeting physical activity, sleep, and diet

Interventions

Lifestyle intervention targeting physical activity, sleep, and diet BEHAVIORAL

Ecological momentary interventions targeting physical activity, sleep, and diet

Active/Active arm; Active/Control Arm; Control/Active Arm

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are currently enrolled in the Singapore Population Health Studies - Multi-Ethnic Cohort Phase 3 (MEC3) or Second Follow-up (F2),
• are of Chinese, Malay, or Indian ethnicity,
• are 21 to 69 years old, and
• can read and write English,
• own or use a smartphone (iOS ≥ 12.4 or Android ≥ 8 with at least 5 GB of free storage, and data plan and internet access),
• are able and willing to download and use study smartphone apps,
• are able and willing to wear the smartwatch provided throughout the study period, and
• can walk independently.

You may not qualify if:

• have a history or current condition of stroke, heart attack, kidney failure, diabetes mellitus, thyroid disease, or cancer, or have had a vascular bypass surgery or angioplasty procedure (either stent or balloon) performed, or
• a serious mental health condition including schizophrenia, psychotic depression, or severe dementia, or
• are currently pregnant or planning to get pregnant during the study period, or
• are participating or planning to participate in other lifestyle intervention studies.
• have a known sensitivity to medical-grade adhesives or a bleeding disorder will be \[applicable to continuous glucose monitoring component only\]
• with contraindications specified by the blood pressure monitoring device manufacturer \[applicable to continuous blood pressure monitoring component only\]
• participated in the pilot study \[applicable to main trial only\].

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Saw Swee Hock School of Public Health

Singapore, 117549, Singapore

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Sleep; Diet

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Falk Müller-Riemenschneid, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Yi Xuan Tan, PhD

CONTACT

+65 65164988; sarah.tan@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Factorial microrandomised trial design where participants will be randomised multiple times at various decision points to receive one of many intervention strategies at random, over a 12-month period

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 27, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)