WeArable TeChnology DaTa DriVen DigitAl HealTh COachINg (ACTIVATION)- a Mixed-methods Study

Not Applicable

Recruiting

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

• Registration Number: NCT06752772
• Lead Sponsor: Alexandra Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Status Verified: 2024-08
• Study Start: 2024-08-06
• Study First Submitted QC: 2024-12-29
• Last Update Submitted: 2024-12-29
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in physical activity level	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 Outcome Measures

Name	Time	Method
Engagement and sustainability	Baseline, 3- , 6-, 9-, and 12-month post study enrolment	Duration of wearables wear time will be assessed throughout the study.
Acceptability of the study	6-, 9- and 12-month post study enrolment	In-depth qualitative interviews will be conducted to assess acceptability of the study.
Satisfaction towards the intervention provided	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.
Lifestyle changes (Diet)	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.
Lifestyle changes (Smoking Cessation)	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.
Lifestyle changes (Alcohol Cessation)	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.
Self-efficacy	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.
Quality of Life	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.

Trial Locations

Locations (1)

Alexandra Hospital; 🇸🇬 Singapore, Singapore