The Digital Version of Holistic Healthy Life Education(e2HLE)

The Digital Version of Holistic Healthy Life Education: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Digital version of Holistic Healthy Life Education; Other: Waitlist control

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Leung, PhD; Phone Number: (852) 27665587; Email: angela.ym.leung@polyu.edu.hk
• Study Contact Backup: Name: Huilin Cheng, PhD; Phone Number: (852)27664771; Email: eileen.cheng@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Yan Chai Hospital Social Services Department
    • Contact: Karen Cheung, PhD; Phone Number: (852)92541414; Email: sl-karen.cheung@connect.polyu.hk
    • Contact: Po Yi Foung; Phone Number: (852)24065032; Email: pyfoung@hq.ychss.org.hk
    • Sub-Investigator: Mei Ling Wong
    • Principal Investigator: Po Yi Foung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital version of Holistic Healthy Life Education (e2HLE)	Behavioral: Digital version of Holistic Healthy Life Education; Participants need to attend a two-day workshop related to (1) health risk appraisal and self-care; (2) exercise, fitness and self-acupressure; (3) emotion and stress management; (4) the whole food plant-based (WFPB) diet; and (5) meditation and mindfulness practices, led by a multi-disciplinary team. Before the intervention commences, they will take pre-blood test and further receive the e2HLE with Hera Leto for three months. During the intervention, participants will attend (1) nine weekly workshops pertaining to WFPB diet, exercise, fitness and self-acupressure, and meditation and mindfulness and followed by weekly tele-counselling sessions; (2) three process evaluation practice sharing sessions in the format of focus group, making up a total of twelve sessions. The process evaluation practice sharing sessions will be audio-recorded; (3) mutual support networking platform will be held between case managers and participants within Hera Leto system.
Other: Waitlist-control	Other: Waitlist control; usual care first, then switch to receive the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight change from baseline to post-intervention (kg)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Yan Chai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2024
• Primary Completion (Estimated): February 21, 2026
• Study Completion (Estimated): May 21, 2026

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: healthy lifestyle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No