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

Alexandra Hospital

Status: Enrolling

Conditions: Prediabetes; Hypertension; Overweight/Obesity; Hyperlipidemia; Type 2 Diabetes Mellitus (T2DM); Elevated Blood Pressure

Treatments: Device: Smart watch; Device: Digital Health Coach (DHC); Behavioral: Dashboard with nudging system

Study type: Interventional

Funder types: Other

Identifiers

NCT06752772

DSRB2023/00276

Details and patient eligibility

About

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.

Enrollment: 1,700 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,700 participants in 3 patient groups

Group 1: Smart Watch only

Active Comparator group

Description:

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.

Treatment:

Device: Smart watch

Group 2: Smart watch + dashboard with nudging system

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dashboard with nudging system

Device: Smart watch

Group 3: Smart watch + dashboard with nudging system + Digital Health Coach (DHC)

Experimental group

Description:

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.

Treatment:

Behavioral: Dashboard with nudging system

Device: Digital Health Coach (DHC)

Device: Smart watch