Clinical trial NCT06499961: The Digital Version of Holistic Healthy Life Education(e2HLE)
Official title: The Digital Version of Holistic Healthy Life Education: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: healthy lifestyle
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Yan Chai Hospital
First posted: 2024-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Intrinsic capacity
timeFrame: 3 months
measure: Heart rate variability
timeFrame: 3 months
measure: Waist circumstance
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Concentration of high density lipoprotein cholesterol (HDL)
timeFrame: 3 months
measure: Concentration of blood glucose
timeFrame: 3 months
measure: Concentration of triglycerides
timeFrame: 3 months
measure: Visceral fat area
timeFrame: 3 months
measure: Chinese version of the Pittsburgh sleep quality questionnaire
timeFrame: 3 months
measure: Chinese version of WHO self-care scale
timeFrame: 3 months
measure: Chinese version of Geriatric Depression Scale
timeFrame: 3 months
measure: Chinese version of the Perceived Stress Scale
timeFrame: 3 months
measure: Wong-Baker Face Pain Rating Scale
timeFrame: 3 months
measure: The Chinese version of the Brief Pain Inventory
timeFrame: 3 months
measure: Chinese version of Medical Outcomes Study Social Support Survey
timeFrame: 3 months
measure: Chinese version of the General Self-efficacy Scale
timeFrame: 3 months
measure: Digital Health Literacy Scale
timeFrame: 3 months
measure: Chinese version of the Five facet mindfulness questionnaire
timeFrame: 3 months
measure: Mindfulness
timeFrame: 3 months
measure: Chinese version of Self-compassion Scale Short-Form
timeFrame: 3 months
measure: Chinese version of Sense of Coherence Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Yan Chai Hospital Social Services Department
Study officials:
References: