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NCT Number: NCT06752772

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.

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Key information

Conditions

Elevated Blood Pressure Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight/Obesity Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Type 2 Diabetes Mellitus (T2DM) Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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.

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.

Treatment and study plan

Smart watch

Device

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

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Engagement and sustainability

    Time frame: Baseline, 3- , 6-, 9-, and 12-month post study enrolment

    Duration of wearables wear time will be assessed throughout the study.

  2. Acceptability of the study

    Time frame: 6-, 9- and 12-month post study enrolment

    In-depth qualitative interviews will be conducted to assess acceptability of the study.

  3. Satisfaction towards the intervention provided

    Time frame: 6-month post study enrolment

    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.

  4. Lifestyle changes (Diet)

    Time frame: Baseline, 6-, and 12-month post enrolment

    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.

  5. Lifestyle changes (Smoking Cessation)

    Time frame: Baseline, 6-, and 12-month post enrolment

    Changes in smoking behaviour will be measured through Cigarette Dependence Scale (CDS-12). Higher score indicates a greater level of possible cigarette dependence.

  6. Lifestyle changes (Alcohol Cessation)

    Time frame: Baseline, 6-, and 12-month post enrolment

    Changes in alcohol consumption will be measured through Alcohol User Disorders Identification Test (AUDIT). Higher score indicates a greater level of possible alcohol dependence.

  7. Self-efficacy

    Time frame: Baseline, 6-, and 12-month post enrolment

    Self-efficacy will be measured through General Self-Efficacy (GSE) Scale. Higher score indicates a greater level of self-efficacy.

  8. Quality of Life

    Time frame: Baseline, 6-, and 12-month post enrolment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elya Elya

CONTACT

[email protected]

96505306

Jacqueline Lau

CONTACT

[email protected]

96505306

Sponsors and collaborators

Lead sponsor

Alexandra Hospital

Other

Collaborators

  • National University of Singapore

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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