The Digital Version of Holistic Healthy Life Education(e2HLE)
- Conditions
- Hypertension
- Interventions
- Behavioral: Digital version of Holistic Healthy Life EducationOther: Waitlist control
- Registration Number
- NCT06499961
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- aged 50 years old or above,
- able to use internet and tablet;
- education level of primary or above;
- understand Chinese and speak Cantonese;
- have central obesity (waist circumference: male >90 cm, female >80 cm) and two of the following: (a) hypertension (systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), (b) hyperglycemia (fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) or (c) previously diagnosed type 2 diabetes), (d) hyperlipidemia (triglyceride concentrations ≥150 mg/dL (1.7 mmol/L), or treatment for this lipid abnormality); HDL cholesterol;40 mg/dL (1.03 mmol/L) in males and 50 mg/dL (1.29 mmol/L) in females, or treatment for this lipid abnormality), (e) BMI over 23; and chronic pain or bad mood caused by the psychosomatic disorder for no less than six months
- have at least 2 of the following distressing symptoms due to psychosomatic or pain and stress symptoms, including physical and mental agitation, feeling tired, often crying, feeling angry/depressed, feeling isolated from family and friends, feeling great stress, insomnia, health is worse than before.
- non-Chinese nationality or can't speak Cantonese;
- participating in any cancer treatment;
- will leave Hong Kong within a short period or the next three months;
- participating in another experiment; living in or planning to live in a facility-care home;
- cognitive difficulties (SPMSQ score equal to or lower than 4);
- taking medications such as estrogenic, synthetic glucocorticoids, anti-steroids, and antiepileptic drugs which may affect cortisol levels.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description digital version of Holistic Healthy Life Education (e2HLE) Digital version of Holistic Healthy Life Education - Waitlist-control Waitlist control -
- Primary Outcome Measures
Name Time Method Weight loss 3 months Weight change from baseline to post-intervention (kg)
- Secondary Outcome Measures
Name Time Method Heart rate variability 3 months measured in milliseconds by Hera Leto system, which is a home-based digital system
Visceral fat area 3 months Measured by bioelectrical Impedance Analysis (Tanita) in units of area (cm2)
Concentration of high density lipoprotein cholesterol (HDL) 3 months Through blood test (mg/dL)
Chinese version of Geriatric Depression Scale 3 months 15-item scale for measuring depression; a range of 0-15; a score of \>5 indicating depression
Chinese version of the Perceived Stress Scale 3 months 14-item scale for measuring stress level; a range from 0 to 56; a higher score indicates more perceived stress
Wong-Baker Face Pain Rating Scale 3 months it measures pain severity with a range from 0 to 10
Intrinsic capacity 3 months 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
Concentration of blood glucose 3 months Through blood test (mmol/L)
Concentration of triglycerides 3 months Through blood test (mg/dL)
The Chinese version of the Brief Pain Inventory 3 months It has 9 items measuring pain intensity
Chinese version of the Pittsburgh sleep quality questionnaire 3 months measured by 19-item scale, a range of 0-21; higher scores indicate worse sleep quality)
Mindfulness 3 months 30-item Chinese version of Nonattachment Scale (a total mean score from 0 to 6, with a higher average score corresponding to higher nonattachment)
Chinese version of Self-compassion Scale Short-Form 3 months 12-item scale; a total score between 16 and 80, a higher score indicating higher self-compassion)
Chinese version of the General Self-efficacy Scale 3 months 10-item scale with a range from 10 to 40, with a higher score indicating more self-efficacy
Waist circumstance 3 months Using a measuring tape (cm)
Blood pressure 3 months Using a sphygmomanometer (mmHg)
Chinese version of WHO self-care scale 3 months 6-item scale for measuring self-care capacity; a range of 6 to 18, with a higher score indicating low self-care ability
Chinese version of Medical Outcomes Study Social Support Survey 3 months 20-item, with a score ranging from 0 to 100, with a higher score indicating better perceived social support.
Chinese version of the Five facet mindfulness questionnaire 3 months 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
Chinese version of Sense of Coherence Scale 3 months 13-item scale; a total score range from 13 to 91,a higher score indicating a stronger sense of coherence)
Digital Health Literacy Scale 3 months 8-item scale with a range from 8 to 40, with higher scores indicating higher perceived eHealth literacy)
Trial Locations
- Locations (1)
Yan Chai Hospital Social Services Department
🇭🇰Hong Kong, Hong Kong