WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study
NCT ID: NCT06752772
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1700 participants
INTERVENTIONAL
2024-08-06
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
75 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
Alexandra Hospital
OTHER
Responsible Party
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Locations
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Alexandra Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSRB2023/00276
Identifier Type: -
Identifier Source: org_study_id
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