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

The Hong Kong Polytechnic University1 site in 1 country150 target enrollmentJune 22, 2024

ConditionsHypertension

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypertension
Sponsor: The Hong Kong Polytechnic University
Enrollment: 150
Locations: 1
Primary Endpoint: Weight loss
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 22, 2024

End Date

May 21, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hong Kong Polytechnic University

Responsible Party

Principal Investigator

Dr Angela Leung

Professor

The Hong Kong Polytechnic University

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.