Elevated Blood PressureNCT06752772
WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study
A study testing Smart watch, Dashboard with nudging system and Digital Health Coach (DHC) in people with Elevated Blood Pressure and Hypertension, run by Alexandra Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Elevated Blood Pressure, Hypertension, Overweight/Obesity
- What is being tested?
- Smart watch, Dashboard with nudging system and Digital Health Coach (DHC)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Aug 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Alexandra Hospital
Singapore
ACTIVATION Team, 96505306, ah_activation@nuhs.edu.sg
About this 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.
- Conditions
- Elevated Blood Pressure, Hypertension, Overweight/Obesity, Type 2 Diabetes Mellitus (T2DM), Hyperlipidemia, Prediabetes
- Being tested
- Smart watch, Dashboard with nudging system, Digital Health Coach (DHC)
- Keywords
- Digital Health Intervention, Health Coaching, Personalisation, Nudging, Wearables
- Medical subject headings
- Hypertension, Overweight, Obesity, Diabetes Mellitus, Type 2, Hyperlipidemias, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart watchDevice
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.
Dashboard with nudging systemBehavioural
Nudges will be sent to participants' smart watch/mobile application with messages that are designed to motivate them to lead a healthy lifestyle.
Digital Health Coach (DHC)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Smart Watch only | Active comparator | 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. Receives: Device: Smart watch |
| Group 2: Smart watch + dashboard with nudging system | Active comparator | 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. Receives: Device: Smart watch; Behavioral: Dashboard with nudging system |
| Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC) | Experimental | 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. Receives: Device: Smart watch; Behavioral: Dashboard with nudging system; Device: Digital Health Coach (DHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6- and 12-month post study enrolment
Secondary outcomes (8)
Engagement and sustainability
Duration of wearables wear time will be assessed throughout the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6-, and 12-month post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start6 Aug 2024
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752772
- Sponsor's protocol ID
- DSRB2023/00276
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06752772
- Acronym / sponsor ID
- DSRB2023/00276
- Conditions
- Elevated Blood Pressure, Hypertension, Overweight/Obesity, Type 2 Diabetes Mellitus (T2DM), Hyperlipidemia, Prediabetes
- Keywords
- Digital Health Intervention, Health Coaching, Personalisation, Nudging, Wearables
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Smart Watch only | Active comparator | Device: Smart watchParticipants 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 comparator | Device: Smart watch, Behavioral: Dashboard with nudging systemParticipants 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) | Experimental | Device: Smart watch, Behavioral: Dashboard with nudging system, Device: 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 21-75 years old
- Patients who are at risk of any of the following:
- Patients who have one or more of the following (HOLD) conditions:
- Patients who own a smartphone
- Patients who are willing to wear a smartwatch during the intervention period.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart watchParticipants 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. | Device | Group 1: Smart Watch only, Group 2: Smart watch + dashboard with nudging system, Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC) |
| Dashboard with nudging systemNudges will be sent to participants' smart watch/mobile application with messages that are designed to motivate them to lead a healthy lifestyle. | Behavioural | Group 2: Smart watch + dashboard with nudging system, Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC) |
| 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. | Device | Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC) |
Primary outcome
Changes in physical activity level
Time frame: Baseline, 6- and 12-month post study enrolment
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart watch, Dashboard with nudging system and Digital Health Coach (DHC) in people with Elevated Blood Pressure and Hypertension, run by Alexandra Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elya Elya (96505306, ah_activation@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in physical activity level (time frame: Baseline, 6- and 12-month post study enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.