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Recruiting NCT06752772

WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study

No phase Interventional Elevated Blood Pressure Hypertension Overweight/Obesity Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smart watch, Dashboard with nudging system, Digital Health Coach (DHC).
Who it may be relevant to
Registry conditions: Elevated Blood Pressure, Hypertension, Overweight/Obesity, Type 2 Diabetes Mellitus (T2DM). Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Public health priorities have shifted towards disease prevention, emphasising health promotion and lifestyle interventions to reduce disease burden. Despite global efforts, the prevalence of chronic diseases remains high, with lifestyle factors such as alcohol consumption, diet, smoking, obesity, and sedentary behaviour playing significant roles. In Singapore, suboptimal lifestyle behaviours are common, contributing to a high incidence of chronic conditions. Metabolic syndrome (MetS), linked to obesity, poses a growing societal burden due to its association with cardiovascular risks. Disparities exist in the delivery of lifestyle interventions among healthcare providers (HCPs), with many patients receiving inadequate guidance. Digital health coaching, incorporating wearable technology, offers promising solutions to bridge these gaps, providing personalised, real-time support and feedback to improve lifestyle behaviours and prevent disease progression. Challenges such as time constraints, lack of feedback, and limited support can be addressed through remote monitoring and tailored interventions, making scalable population-level interventions feasible.

Interventions

  • Device Smart watch
    Participants are required to wear the study issued smart watch for at least 8 hours a day during the intervention period and are encouraged to wear it beyond the study intervention period.
  • Behavioral Dashboard with nudging system
    Nudges will be sent to participants' smart watch/mobile application with messages that are designed to motivate them to lead a healthy lifestyle.
  • Device Digital Health Coach (DHC)
    Participants will be assigned to a DHC and the DHC will be providing them with remote health coaching assistance for a duration of 6 months, upon successful enrolment.

Primary outcome measures

  • Changes in physical activity level [Time frame: Baseline, 6- and 12-month post study enrolment]
Secondary outcome measures (8)
  • Engagement and sustainability [Time frame: Baseline, 3- , 6-, 9-, and 12-month post study enrolment]
  • Acceptability of the study [Time frame: 6-, 9- and 12-month post study enrolment]
  • Satisfaction towards the intervention provided [Time frame: 6-month post study enrolment]
  • Lifestyle changes (Diet) [Time frame: Baseline, 6-, and 12-month post enrolment]
  • Lifestyle changes (Smoking Cessation) [Time frame: Baseline, 6-, and 12-month post enrolment]
  • Lifestyle changes (Alcohol Cessation) [Time frame: Baseline, 6-, and 12-month post enrolment]
  • Self-efficacy [Time frame: Baseline, 6-, and 12-month post enrolment]
  • Quality of Life [Time frame: Baseline, 6-, and 12-month post enrolment]

Eligibility criteria

Inclusion criteria

  • 21-75 years old
  • Patients who are at risk of any of the following:
  • Elevated blood pressure
  • Overweight (BMI>=23kg/m2)
  • Pre-diabetes, OR
  • Patients who have one or more of the following (HOLD) conditions:
  • Hypertension
  • Obesity (BMI>=27.5kg/m2)
  • HyperLipidemia
  • Type 2 Diabetes Mellitus
  • Patients who own a smartphone
  • Patients who are willing to wear a smartwatch during the intervention period.

Exclusion criteria

  • Patients who have a medical condition that prevented participation in physical activity
  • Patients who have current diagnosis or history of eating disorder, depression
  • Patients who are currently pregnant or planning to become pregnant in the next 6 months
  • Patients who are currently participating in a weight loss programme (commercial, medically supervised, or research study)
  • Patients who are on weight loss medications (over-the-counter or prescription)
  • Patients who are not mentally-, physically- or technologically-capable
  • Patients who is unable to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Singapore · 1 center
  • Alexandra Hospital — Singapore

Identifiers

NCT: NCT06752772 · DSRB2023/00276

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗