WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study
1 other identifier
interventional
1,700
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedOctober 2, 2025
September 1, 2025
1.2 years
July 25, 2024
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in physical activity level
Change in physical activity level will be measured using the International Physical Activity Questionnaire Short Form (IPAQ-SF) scale at baseline, 6- and 12-month post study enrolment. Higher score indicates a higher level of physical activity.
Baseline, 6- and 12-month post study enrolment
Secondary Outcomes (8)
Engagement and sustainability
Baseline, 3- , 6-, 9-, and 12-month post study enrolment
Acceptability of the study
6-, 9- and 12-month post study enrolment
Satisfaction towards the intervention provided
6-month post study enrolment
Lifestyle changes (Diet)
Baseline, 6-, and 12-month post enrolment
Lifestyle changes (Smoking Cessation)
Baseline, 6-, and 12-month post enrolment
- +3 more secondary outcomes
Study Arms (3)
Group 1: Smart Watch only
ACTIVE COMPARATORParticipants will need to undergo HbA1c and lipid blood tests to determine if they have pre-diabetes, diabetes, or hyperlipidemia if they lack recent blood results (within 3 months prior to enrolment) for blood glucose and/or lipid levels. Participants assigned to Group 1 are required to fill out questionnaires covering aspects such as sociodemographic, lifestyle, medical condition, healthcare utilisation, quality of life, self-efficacy, distress and personality measures at study baseline, as well as at 3-, 6-, 9-, and 12-months following study enrolment. Participants will be issued a Fitbit Smartwatch and are required to wear the smart watch for at least 8 hours a day for a total duration of 6 months. Participants are encouraged to continue their normal daily activities while wearing the smart watch.
Group 2: Smart watch + dashboard with nudging system
ACTIVE COMPARATORParticipants will need to undergo HbA1c and lipid blood tests to determine if they have pre-diabetes, diabetes, or hyperlipidemia if they lack recent blood results (within 3 months prior to enrolment) for blood glucose and/or lipid levels. Participants assigned to Group 2 are required to fill out questionnaires covering aspects such as sociodemographic, lifestyle, medical condition, healthcare utilisation, quality of life, self-efficacy, distress and personality measures at study baseline, as well as at 3-, 6-, 9-, and 12-months following study enrolment. Participants will be issued a Fitbit Smartwatch and are required to wear the smart watch for at least 8 hours a day for a total duration of 6 months. Participants are encouraged to continue their normal daily activities while wearing the smart watch.
Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC)
EXPERIMENTALParticipants will need to undergo HbA1c and lipid blood tests to determine if they have pre-diabetes, diabetes, or hyperlipidemia if they lack recent blood results (within 3 months prior to enrolment) for blood glucose and/or lipid levels. Participants assigned to Group 3 are required to fill out questionnaires covering aspects such as sociodemographic, lifestyle, medical condition, healthcare utilisation, quality of life, self-efficacy, distress and personality measures at study baseline, as well as at 3-, 6-, 9-, and 12-months following study enrolment. Participants will be issued a Fitbit Smartwatch and are required to wear the smart watch for at least 8 hours a day for a total duration of 6 months. Participants will be assigned to a DHC and the DHC will be providing you with remote health coaching assistance for a duration of 6 months. Participants are encouraged continue their normal daily activities while wearing the smart watch.
Interventions
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.
Nudges will be sent to participants' smart watch/mobile application with messages that are designed to motivate them to lead a healthy lifestyle.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexandra Hospitallead
- National University of Singaporecollaborator
Study Sites (1)
Alexandra Hospital
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
December 31, 2024
Study Start
August 6, 2024
Primary Completion
November 1, 2025
Study Completion
February 1, 2026
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share