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临床试验/NCT05284162
NCT05284162Unknown不适用

Effects of a Theory-guided Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk: a Randomised Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
202
试验地点
1
主要终点
Change in health promoting behaviours

研究概览

简要总结

Cardiometabolic disease has been an increasing trend globally and remains the major cause of morbidity and mortality in Hong Kong. Health coaching intervention are generally effective for managing chronic disease and prevention of complication. However, there is fewer attention on the effects of health coaching in primary disease prevention. This study aims to evaluate the effects of health coaching programme on increasing health promoting behaviours in middle-aged adults with cardiometabolic risk.

详细描述

Cardiometabolic disease, including metabolic syndrome, prediabetes, type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke, has been an increasing trend globally, and increased more than double over 5 years in China [1].

Cardiometabolic disease remains the major cause of morbidity and mortality in Hong Kong [2]. Type 2 diabetes mellitus is associated with increased risk for morbidity and mortality [3]. Ischaemic heart disease and stroke were the major cause of disability-adjusted life years (DALYs) worldwide, resulting in dependence, disability and cognitive impairment [4]. Moreover, midlife stroke risk is associated with cognitive decline within 10 years [5].

A local population health survey has reported that 41.1% of persons between the ages of 45 and 64 are at medium-to-high risk of developing cardiovascular diseases over the next 10 years [6]. Most of the cardiometabolic diseases are attributable to health behaviours. An international study identified risk factors for coronary heart disease and validated the non-laboratory INTERHEART Risk Score (IHRS), which is mainly calculated based on behavioural risk factors, including smoking, stress and physical activity [7]. Also, another study among 32 countries in Asia, Africa, Australia, Europe, the Middle East and USA reported that over 90% of the population attributable risks of stroke could be explained by behavioural risk factors measured by IHRS [8]. Proactive measures to moderate these modifiable risk factors are crucial to halt the increasing trend of cardiometabolic disease.

Health coaching interventions are generally effective for managing chronic diseases, including cancer, heart disease, diabetes and hypertension [9]. A systematic review reported health coaching significantly increased physical activity, improved physical and mental health status in patients with chronic disease [10]. Health coaching interventions assist patients to participate actively in their health care, and health coaches collaborate with patients by giving support and promoting self-efficacy in disease management [11]. Despite the widespread use of evidence based health coaching in chronic disease management and prevention of complication, there is fewer attention on the effects of health coaching in primary disease prevention.

Therefore, a large-scale, robust clinical trial examining the effects of health coaching in reducing the cardiometabolic risk in middle-aged adults is warranted. The purpose of this study is to address the research gap by evaluating the effects of health coaching programme on increasing health promoting behaviours in middle-aged adults with cardiometabolic risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 40-64 years;
  • have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher;
  • can communicate in Cantonese;
  • able to give informed consent.

排除标准

  • previous diagnosis of transient ischemic attack, stroke, myocardial infarction, atrial fibrillation, coronary heart disease, heart failure, dementia and chronic renal failure;
  • currently on medication to control hyperlipidemia, diabetes or hypertension;
  • with eye or retinal disease;
  • diagnosis of terminal disease with an expected life expectancy less than 12 months;
  • currently participating in any other clinical trial;
  • currently participating in any other structured lifestyle-based or exercise-based programme.

结局指标

主要结局

Change in health promoting behaviours

时间窗: Change from baseline at 3 months and 6 months post allocation

The Chinese version of Health Promoting Lifestyle Profile II (HPLP II) , including health responsibility (9 items), nutrition (9 items), physical activity (8 items) and stress management (8 items), measure the practice of health-promoting behaviours

次要结局

  • Change in blood total cholesterol(Change from baseline at 3 months and 6 months post allocation)
  • Change in diastolic blood pressure(Change from baseline at 3 months and 6 months post allocation)
  • Change in blood glucose(Change from baseline at 3 months and 6 months post allocation)
  • Change in physical activities(Change from baseline at 3 months and 6 months post allocation)
  • Change in cardiometabolic risk(Change from baseline at 3 months and 6 months post allocation)
  • Change in stroke risk(Change from baseline at 3 months and 6 months post allocation)
  • Change in self-efficacy of adopting health promoting behaviours(Change from baseline at 3 months and 6 months post allocation)
  • Change in sleep quality(Change from baseline at 3 months and 6 months post allocation)
  • Change in Body Mass Index(Change from baseline at 3 months and 6 months post allocation)
  • Change in blood urate(Change from baseline at 3 months and 6 months post allocation)
  • Change in psychological distress(Change from baseline at 3 months and 6 months post allocation)
  • Change in systolic blood pressure(Change from baseline at 3 months and 6 months post allocation)
  • Change in waist-hip-ratio(Change from baseline at 3 months and 6 months post allocation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoe Ching Man Kwok

Principal Investigator, Lecturer

Chinese University of Hong Kong

研究点 (1)

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