The Digital Version of Holistic Healthy Life Education(e2HLE)
NCT Number: NCT06499961
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: BEHAVIORAL: Digital version of Holistic Healthy Life Education|OTHER: Waitlist control
Sponsor: The Hong Kong Polytechnic University
Collaborators: Yan Chai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-22
Completion Date: 2026-05-21
Locations: Yan Chai Hospital Social Services Department, Hong Kong, Hong Kong

Summary:
The digital version of Holistic Healthy Life Education" (e2HLE) is a holistic, person-centric, multi-component and lifestyle modification intervention that we developed, alongside the WHO integrated care for older people (ICOPE) model and a home-based self-monitoring bio-signals system "Hera Leto". This randomized controlled trial aims to evaluate the effectiveness of e2HLE intervention for achieving weight loss and enhancing self-care and intrinsic capacity (i.e. psychological and mental wellbeing, vitality and nutritional health) as well as improving cardio-metabolic profiles (e.g. blood pressure and lipid profile) compared to usual care.

Primary Outcome Measures: Weight loss, Weight change from baseline to post-intervention (kg), 3 months
Secondary Outcome Measures: Intrinsic capacity, WHO ICOPE tool including five domains: cognitive, locomotor, sensory, vision, and psychological capacity. A total score ranges from 0 to 6, a higher score indicating a poor intrinsic capacity, 3 months|Heart rate variability, measured in milliseconds by Hera Leto system, which is a home-based digital system, 3 months|Waist circumstance, Using a measuring tape (cm), 3 months|Blood pressure, Using a sphygmomanometer (mmHg), 3 months|Concentration of high density lipoprotein cholesterol (HDL), Through blood test (mg/dL), 3 months|Concentration of blood glucose, Through blood test (mmol/L), 3 months|Concentration of triglycerides, Through blood test (mg/dL), 3 months|Visceral fat area, Measured by bioelectrical Impedance Analysis (Tanita) in units of area (cm2), 3 months|Chinese version of the Pittsburgh sleep quality questionnaire, measured by 19-item scale, a range of 0-21; higher scores indicate worse sleep quality), 3 months|Chinese version of WHO self-care scale, 6-item scale for measuring self-care capacity; a range of 6 to 18, with a higher score indicating low self-care ability, 3 months|Chinese version of Geriatric Depression Scale, 15-item scale for measuring depression; a range of 0-15; a score of \>5 indicating depression, 3 months|Chinese version of the Perceived Stress Scale, 14-item scale for measuring stress level; a range from 0 to 56; a higher score indicates more perceived stress, 3 months|Wong-Baker Face Pain Rating Scale, it measures pain severity with a range from 0 to 10, 3 months|The Chinese version of the Brief Pain Inventory, It has 9 items measuring pain intensity, 3 months|Chinese version of Medical Outcomes Study Social Support Survey, 20-item, with a score ranging from 0 to 100, with a higher score indicating better perceived social support., 3 months|Chinese version of the General Self-efficacy Scale, 10-item scale with a range from 10 to 40, with a higher score indicating more self-efficacy, 3 months|Digital Health Literacy Scale, 8-item scale with a range from 8 to 40, with higher scores indicating higher perceived eHealth literacy), 3 months|Chinese version of the Five facet mindfulness questionnaire, 20-item scale; each facet score is the average of the four items, ranging from 1 to 5, with higher scores indicating higher mindfulness levels, 3 months|Mindfulness, 30-item Chinese version of Nonattachment Scale (a total mean score from 0 to 6, with a higher average score corresponding to higher nonattachment), 3 months|Chinese version of Self-compassion Scale Short-Form, 12-item scale; a total score between 16 and 80, a higher score indicating higher self-compassion), 3 months|Chinese version of Sense of Coherence Scale, 13-item scale; a total score range from 13 to 91,a higher score indicating a stronger sense of coherence), 3 months