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

ConditionsPhysical ActivityDiet QualitySleepCardiometabolic HealthDigital Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-69
SponsorNational University of Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Lifestyle intervention targeting physical activity, sleep, and diet

    Behavioral

    Ecological momentary interventions targeting physical activity, sleep, and diet

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: Pure Control ArmNo intervention 0 interventions
Group B: Active/Control ArmExperimental treatment 1 intervention
Group C: Control/Active ArmExperimental treatment 1 intervention
Group D: Active/Active armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants having sufficient physical activity

Based on self-report and devices

Time frame
At baseline, and every 5 weeks, up to 52 weeks from joining the study
2

Number of participants having sufficient sleep

Based on self-report and devices

Time frame
At baseline, and every 5 weeks, up to 52 weeks from joining the study
3

Number of participants meeting dietary guidelines

Based on self-report

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

Secondary outcomes

1

Glycaemic response

Measured using continuous glucose monitors

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: