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NCT Number: NCT06499961

The Digital Version of Holistic Healthy Life Education(e2HLE)

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Waitlist Control

Other

usual care first, then switch to receive the intervention

Primary outcomes

  1. Weight loss

    Time frame: 3 months

    Weight change from baseline to post-intervention (kg)

Secondary outcomes

  1. Intrinsic capacity

    Time frame: 3 months

    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

  2. Heart rate variability

    Time frame: 3 months

    measured in milliseconds by Hera Leto system, which is a home-based digital system

  3. Waist circumstance

    Time frame: 3 months

    Using a measuring tape (cm)

  4. Blood pressure

    Time frame: 3 months

    Using a sphygmomanometer (mmHg)

  5. Concentration of high density lipoprotein cholesterol (HDL)

    Time frame: 3 months

    Through blood test (mg/dL)

  6. Concentration of blood glucose

    Time frame: 3 months

    Through blood test (mmol/L)

  7. Concentration of triglycerides

    Time frame: 3 months

    Through blood test (mg/dL)

  8. Visceral fat area

    Time frame: 3 months

    Measured by bioelectrical Impedance Analysis (Tanita) in units of area (cm2)

  9. Chinese version of the Pittsburgh sleep quality questionnaire

    Time frame: 3 months

    measured by 19-item scale, a range of 0-21; higher scores indicate worse sleep quality)

  10. Chinese version of WHO self-care scale

    Time frame: 3 months

    6-item scale for measuring self-care capacity; a range of 6 to 18, with a higher score indicating low self-care ability

  11. Chinese version of Geriatric Depression Scale

    Time frame: 3 months

    15-item scale for measuring depression; a range of 0-15; a score of >5 indicating depression

  12. Chinese version of the Perceived Stress Scale

    Time frame: 3 months

    14-item scale for measuring stress level; a range from 0 to 56; a higher score indicates more perceived stress

  13. Wong-Baker Face Pain Rating Scale

    Time frame: 3 months

    it measures pain severity with a range from 0 to 10

  14. The Chinese version of the Brief Pain Inventory

    Time frame: 3 months

    It has 9 items measuring pain intensity

  15. Chinese version of Medical Outcomes Study Social Support Survey

    Time frame: 3 months

    20-item, with a score ranging from 0 to 100, with a higher score indicating better perceived social support.

  16. Chinese version of the General Self-efficacy Scale

    Time frame: 3 months

    10-item scale with a range from 10 to 40, with a higher score indicating more self-efficacy

  17. Digital Health Literacy Scale

    Time frame: 3 months

    8-item scale with a range from 8 to 40, with higher scores indicating higher perceived eHealth literacy)

  18. Chinese version of the Five facet mindfulness questionnaire

    Time frame: 3 months

    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

  19. Mindfulness

    Time frame: 3 months

    30-item Chinese version of Nonattachment Scale (a total mean score from 0 to 6, with a higher average score corresponding to higher nonattachment)

  20. Chinese version of Self-compassion Scale Short-Form

    Time frame: 3 months

    12-item scale; a total score between 16 and 80, a higher score indicating higher self-compassion)

  21. Chinese version of Sense of Coherence Scale

    Time frame: 3 months

    13-item scale; a total score range from 13 to 91,a higher score indicating a stronger sense of coherence)

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Leung, PhD

CONTACT

[email protected]

(852) 27665587

Huilin Cheng, PhD

CONTACT

[email protected]

(852)27664771

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Yan Chai Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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