Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
ID06752772

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

Led by Alexandra Hospital · Updated on 2025-10-02

1700

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

A

Alexandra Hospital

Lead Sponsor

N

National University of Singapore

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how digital health coaching combined with wearable technology can help improve lifestyle behaviors to prevent and manage chronic conditions such as elevated blood pressure, obesity, prediabetes, type 2 diabetes, and hyperlipidemia. The trial focuses on addressing gaps in lifestyle intervention delivery by healthcare providers and explores scalable, personalized support through remote monitoring and feedback. The study is a mixed-methods, randomized trial aiming to evaluate these approaches in adults at risk or with these metabolic-related conditions. Participants are randomly assigned to one of three groups: Group 1 receives a smart watch only; Group 2 receives a smart watch plus access to a dashboard with a nudging system that sends motivational messages; and Group 3 receives a smart watch, the dashboard with nudges, plus remote health coaching from a digital health coach for six months. All participants will wear the Fitbit smart watch for at least eight hours daily over six months while continuing their normal activities. Questionnaires on lifestyle, health, and quality of life are completed at baseline and at several intervals up to 12 months. Throughout the study, participants undergo blood tests if recent results are unavailable to assess blood glucose and lipids. They complete questionnaires at baseline, 3, 6, 9, and 12 months to measure lifestyle changes, quality of life, self-efficacy, and satisfaction with the intervention. Physical activity levels are tracked at baseline, 6, and 12 months. The trial includes safety monitoring and engagement assessments, with participants encouraged to maintain usual care with their healthcare providers. The total participation spans one year with ongoing data collection and follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 21 and 75 years
  • At risk of elevated blood pressure, overweight (BMI ≥23 kg/m2), or prediabetes
  • Or diagnosed with hypertension, obesity (BMI ≥27.5 kg/m2), hyperlipidemia, or type 2 diabetes mellitus
  • Own a smartphone
  • Willing to wear a smartwatch during the intervention period
Not Eligible

You will not qualify if you...

  • Medical condition preventing participation in physical activity
  • Current diagnosis or history of eating disorder or depression
  • Currently pregnant or planning pregnancy within 6 months
  • Participating in a weight loss program or using weight loss medications
  • Not mentally, physically, or technologically capable
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - 6 months

Participants are given a Fitbit Smartwatch to wear for at least 8 hours a day during the 6-month intervention period. Some participants will also receive access to a dashboard with motivational nudges, and others will be assigned a Digital Health Coach providing remote health coaching for 6 months.

Questionnaires at baseline, 3, 6, 9, and 12 months after enrollment

Long-term Monitoring

Duration - Up to 12 months from enrollment

Participants continue to be observed for changes in physical activity, lifestyle, and quality of life up to 12 months after enrollment.

Questionnaires at 9 and 12 months after enrollment

Trial Site Locations

Total: 1 location

1

Alexandra Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

E

Elya Elya

J

Jacqueline Lau

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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