NCT06499961招募中不适用
The Digital Version of Holistic Healthy Life Education: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Weight loss
时间窗: 3 months
Weight change from baseline to post-intervention (kg)
次要结局
- Heart rate variability(3 months)
- Visceral fat area(3 months)
- Concentration of high density lipoprotein cholesterol (HDL)(3 months)
- Chinese version of Geriatric Depression Scale(3 months)
- Chinese version of the Perceived Stress Scale(3 months)
- Wong-Baker Face Pain Rating Scale(3 months)
- Concentration of blood glucose(3 months)
- Concentration of triglycerides(3 months)
- The Chinese version of the Brief Pain Inventory(3 months)
- Intrinsic capacity(3 months)
- Chinese version of the Pittsburgh sleep quality questionnaire(3 months)
- Mindfulness(3 months)
- Chinese version of Self-compassion Scale Short-Form(3 months)
- Waist circumstance(3 months)
- Blood pressure(3 months)
- Chinese version of the General Self-efficacy Scale(3 months)
- Chinese version of WHO self-care scale(3 months)
- Chinese version of Medical Outcomes Study Social Support Survey(3 months)
- Chinese version of the Five facet mindfulness questionnaire(3 months)
- Chinese version of Sense of Coherence Scale(3 months)
- Digital Health Literacy Scale(3 months)
研究者
Dr Angela Leung
Professor
The Hong Kong Polytechnic University
研究点 (1)
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