Clinical trial NCT06752772: WeArable TeChnology DaTa DriVen DigitAl HealTh COachINg (ACTIVATION)- a Mixed-methods Study
Official title: WeArable TeChnology DaTa DriVen DigitAl HealTh COachINg (ACTIVATION)- a Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Hypertension
Overweight/obesity
Type 2 Diabetes Mellitus (T2DM)
Hyperlipidemia
Prediabetes
Keywords: Digital Health Intervention
Health Coaching
Personalisation
Nudging
Wearables
Lead sponsor: Alexandra Hospital
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2024-12-31
Enrollment: 1700
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in physical activity level
timeFrame: Baseline, 6- and 12-month post study enrolment
Secondary outcomes:
measure: Engagement and sustainability
timeFrame: Baseline, 3- , 6-, 9-, and 12-month post study enrolment
measure: Acceptability of the study
timeFrame: 6-, 9- and 12-month post study enrolment
measure: Satisfaction towards the intervention provided
timeFrame: 6-month post study enrolment
measure: Lifestyle changes (Diet)
timeFrame: Baseline, 6-, and 12-month post enrolment
measure: Lifestyle changes (Smoking Cessation)
timeFrame: Baseline, 6-, and 12-month post enrolment
measure: Lifestyle changes (Alcohol Cessation)
timeFrame: Baseline, 6-, and 12-month post enrolment
measure: Self-efficacy
timeFrame: Baseline, 6-, and 12-month post enrolment
measure: Quality of Life
timeFrame: Baseline, 6-, and 12-month post enrolment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
Study officials:
References: