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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Hyperlipidemia; Prediabetes; Elevated Blood Pressure; Type 2 Diabetes Mellitus (T2DM); Overweight/Obesity
• Intervention / Treatment: Device: Smart watch; Behavioral: Dashboard with nudging system; Device: Digital Health Coach (DHC)

• Study Type: Interventional
• Enrollment (Estimated): 1700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elya Elya; Phone Number: 96505306; Email: ah_activation@nuhs.edu.sg
• Study Contact Backup: Name: Jacqueline Lau; Phone Number: 96505306; Email: ah_activation@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Alexandra Hospital
    • Contact: ACTIVATION Team; Phone Number: 96505306; Email: ah_activation@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 21-75 years old

• Patients who are at risk of any of the following:

  1. Elevated blood pressure
  2. Overweight (BMI>=23kg/m2)
  3. Pre-diabetes, OR

• Patients who have one or more of the following (HOLD) conditions:

  1. Hypertension
  2. Obesity (BMI>=27.5kg/m2)
  3. HyperLipidemia
  4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Smart Watch only; Participants 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.	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.
Active Comparator: Group 2: Smart watch + dashboard with nudging system; Participants 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.	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.
Experimental: Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC); Participants 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement and sustainability	Duration of wearables wear time will be assessed throughout the study.	Baseline, 3- , 6-, 9-, and 12-month post study enrolment
Acceptability of the study	In-depth qualitative interviews will be conducted to assess acceptability of the study.	6-, 9- and 12-month post study enrolment
Satisfaction towards the intervention provided	Satisfaction will be measured through Client Satisfaction Questionnaire (CSQ-8) for Group 3 participants. CSQ-8 uses a 4-point Likert scale, with higher score indicating greater satisfaction.	6-month post study enrolment
Lifestyle changes (Diet)	Changes in diet intake will be measured through Healthy Eating Assessment (HEA) scale. Health Benefit score is calculated, and a higher score indicates that participants are in a possible healthier benefit zone.	Baseline, 6-, and 12-month post enrolment
Lifestyle changes (Smoking Cessation)	Changes in smoking behaviour will be measured through Cigarette Dependence Scale (CDS-12). Higher score indicates a greater level of possible cigarette dependence.	Baseline, 6-, and 12-month post enrolment
Lifestyle changes (Alcohol Cessation)	Changes in alcohol consumption will be measured through Alcohol User Disorders Identification Test (AUDIT). Higher score indicates a greater level of possible alcohol dependence.	Baseline, 6-, and 12-month post enrolment
Self-efficacy	Self-efficacy will be measured through General Self-Efficacy (GSE) Scale. Higher score indicates a greater level of self-efficacy.	Baseline, 6-, and 12-month post enrolment
Quality of Life	Changes in quality of life will be measured through EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L). Index scores closer to 1 indicates a better possible health state; a higher EQ-VAS score closer to 100 indicates a better possible health state.	Baseline, 6-, and 12-month post enrolment

Collaborators and Investigators

• Sponsor: Alexandra Hospital
• Collaborators: National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Health Coaching; Digital Health Intervention; Wearables; Nudging; Personalisation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Dyslipidemias; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Diabetes Mellitus, Type 2; Prediabetic State; Hyperlipidemias
• Other Study ID Numbers: DSRB2023/00276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No