The Digital Version of Holistic Healthy Life Education(e2HLE)

NCT06499961 | Recruiting

• 1 other identifier: 03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

healthy lifestyle

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight change from baseline to post-intervention (kg)

  3 months

Secondary Outcomes (21)

• Intrinsic capacity

  3 months

• Heart rate variability

  3 months

• Waist circumstance

  3 months

• Blood pressure

  3 months

• Concentration of high density lipoprotein cholesterol (HDL)

  3 months

Study Arms (2)

digital version of Holistic Healthy Life Education (e2HLE)

EXPERIMENTAL

Behavioral: Digital version of Holistic Healthy Life Education

Waitlist-control

OTHER

Other: Waitlist control

Interventions

Digital version of Holistic Healthy Life Education BEHAVIORAL

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.

digital version of Holistic Healthy Life Education (e2HLE)

Waitlist control OTHER

usual care first, then switch to receive the intervention

Waitlist-control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Yan Chai Hospital: collaborator

Study Sites (1)

Yan Chai Hospital Social Services Department

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Angela Leung, PhD

CONTACT

(852) 27665587; angela.ym.leung@polyu.edu.hk

Huilin Cheng, PhD

CONTACT

(852)27664771; eileen.cheng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: July 15, 2024
• Study Start: June 22, 2024
• Primary Completion: February 21, 2026
• Study Completion (Estimated): May 21, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)