The Digital Version of Holistic Healthy Life Education(e2HLE)

Not Applicable

Recruiting

• Conditions: Hypertension

• 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

Study Timeline

• Study First Submitted: 2024-05-07
• Study Start: 2024-06-22
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-07
• Last Update Submitted: 2024-07-07
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2026-02-21
• Study Completion: 2026-05-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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
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
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
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)
Waist circumstance	3 months	Using a measuring tape (cm)
Blood pressure	3 months	Using a sphygmomanometer (mmHg)
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
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