HypertensionNCT06499961
The Digital Version of Holistic Healthy Life Education(e2HLE)
A study testing Digital version of Holistic Healthy Life Education in people with Hypertension, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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". Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Digital version of Holistic Healthy Life Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jun 2024to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Yan Chai Hospital Social Services Department
Hong Kong
Karen Cheung, PhD, (852)92541414, sl-karen.cheung@connect.polyu.hk
Po Yi Foung, (852)24065032, pyfoung@hq.ychss.org.hk
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Digital version of Holistic Healthy Life Education, Waitlist control
- Keywords
- healthy lifestyle
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital version of Holistic Healthy Life EducationBehavioural
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.
Waitlist controlOther
usual care first, then switch to receive the intervention
| Study group | Role | What they receive |
|---|---|---|
| digital version of Holistic Healthy Life Education (e2HLE) | Experimental | Not described Receives: Behavioral: Digital version of Holistic Healthy Life Education |
| Waitlist-control | Other | Not described Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight change from baseline to post-intervention (kg)
Measured: 3 months
Secondary outcomes (21)
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
Measured: 3 months
Heart rate variability
measured in milliseconds by Hera Leto system, which is a home-based digital system
Measured: 3 months
Waist circumstance
Using a measuring tape (cm)
Measured: 3 months
Blood pressure
Using a sphygmomanometer (mmHg)
Measured: 3 months
Concentration of high density lipoprotein cholesterol (HDL)
Through blood test (mg/dL)
Measured: 3 months
Concentration of blood glucose
Through blood test (mmol/L)
Measured: 3 months
Concentration of triglycerides
Through blood test (mg/dL)
Measured: 3 months
Visceral fat area
Measured by bioelectrical Impedance Analysis (Tanita) in units of area (cm2)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Wong-Baker Face Pain Rating Scale
it measures pain severity with a range from 0 to 10
Measured: 3 months
The Chinese version of the Brief Pain Inventory
It has 9 items measuring pain intensity
Measured: 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.
Measured: 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
Measured: 3 months
Digital Health Literacy Scale
8-item scale with a range from 8 to 40, with higher scores indicating higher perceived eHealth literacy)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start22 Jun 2024
- Primary completion21 Feb 2026 (estimated)
- Study completion21 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Yan Chai Hospital
- Responsible party
- Principal investigator, Dr Angela Leung, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499961
- Sponsor's protocol ID
- 03
- Status last verified
- Jul 2024
- First submitted
- 7 May 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheung KS, Lau BH, Leung AYM. Study protocol on effectiveness of a holistic lifestyle intervention using eHealth system for older adults with metabolic syndrome and psychosomatic symptoms: a randomized controlled trial. BMC Geriatr. 2025 Dec 29;26(1):140. doi: 10.1186/s12877-025-06613-1.
PubMed 41466184
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Digital Version of Holistic Healthy Life Education: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06499961
- Acronym / sponsor ID
- 03
- Conditions
- Hypertension
- Keywords
- healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Yan Chai Hospital
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 21 Feb 2026 (estimated)
- Study completion
- 21 May 2026 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital version of Holistic Healthy Life Education (e2HLE) | Experimental | Behavioral: Digital version of Holistic Healthy Life Education |
| Waitlist-control | Other | Other: Waitlist control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital version of Holistic Healthy Life EducationParticipants 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. | Behavioural | digital version of Holistic Healthy Life Education (e2HLE) |
| Waitlist controlusual care first, then switch to receive the intervention | Other | Waitlist-control |
Primary outcome
Weight loss
Time frame: 3 months
Weight change from baseline to post-intervention (kg)
21 secondary outcomes
Intrinsic capacity
Time frame: 3 months
Heart rate variability
Time frame: 3 months
Waist circumstance
Time frame: 3 months
Blood pressure
Time frame: 3 months
Concentration of high density lipoprotein cholesterol (HDL)
Time frame: 3 months
Concentration of blood glucose
Time frame: 3 months
Concentration of triglycerides
Time frame: 3 months
Visceral fat area
Time frame: 3 months
Chinese version of the Pittsburgh sleep quality questionnaire
Time frame: 3 months
Chinese version of WHO self-care scale
Time frame: 3 months
Chinese version of Geriatric Depression Scale
Time frame: 3 months
Chinese version of the Perceived Stress Scale
Time frame: 3 months
Wong-Baker Face Pain Rating Scale
Time frame: 3 months
The Chinese version of the Brief Pain Inventory
Time frame: 3 months
Chinese version of Medical Outcomes Study Social Support Survey
Time frame: 3 months
Chinese version of the General Self-efficacy Scale
Time frame: 3 months
Digital Health Literacy Scale
Time frame: 3 months
Chinese version of the Five facet mindfulness questionnaire
Time frame: 3 months
Mindfulness
Time frame: 3 months
Chinese version of Self-compassion Scale Short-Form
Time frame: 3 months
Chinese version of Sense of Coherence Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 41466184Cheung KS, Lau BH, Leung AYM. Study protocol on effectiveness of a holistic lifestyle intervention using eHealth system for older adults with metabolic syndrome and psychosomatic symptoms: a randomized controlled trial. BMC Geriatr. 2025 Dec 29;26(1):140. doi: 10.1186/s12877-025-06613-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital version of Holistic Healthy Life Education in people with Hypertension, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Leung, PhD ((852) 27665587, angela.ym.leung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.