Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coaching, Cardiovascular Diseases, Metabolic Diseases

Intervention / Treatment
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* Behavioral: Health coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health coaching<br>Health coaching | Behavioral: Health coaching<br>* The health coaching program includes four monthly health coaching sessions for three months.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health promoting behaviours | 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 | Change from baseline at 3 months and 6 months post allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiometabolic risk | Non-laboratory INTERHEART Risk Score (IHRS) assess the risk of cardiometabolic disease | Change from baseline at 3 months and 6 months post allocation | 
| Change in stroke risk | Automatic retinal image analysis (ARIA)-stroke will be used to quantify stroke risk | Change from baseline at 3 months and 6 months post allocation | 
| Change in self-efficacy of adopting health promoting behaviours | Adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used to rate the participants level of confidence in various behaviours | Change from baseline at 3 months and 6 months post allocation | 
| Change in psychological distress | The Chinese version of the shorter version of Depression Anxiety Stress Scales (DASS) developed by Lovibond and Lovibond in 1995 will be used | Change from baseline at 3 months and 6 months post allocation | 
| Change in sleep quality | The Chinese version of the Pittsburg Sleep Quality Index developed by Buysse and team in 1988 will be used | Change from baseline at 3 months and 6 months post allocation | 
| Change in physical activities | International Physical Activity Questionnaire - Chinese (IPAQ-C), a short version, 9-item scale, will be used to assess the level of physical activities | Change from baseline at 3 months and 6 months post allocation | 
| Change in systolic blood pressure | Blood pressure measurement using an electronic sphygmomanometer | Change from baseline at 3 months and 6 months post allocation | 
| Change in diastolic blood pressure | Blood pressure measurement using an electronic sphygmomanometer | Change from baseline at 3 months and 6 months post allocation | 
| Change in Body Mass Index | Body Mass Index will be calculated by the measured height and weight | Change from baseline at 3 months and 6 months post allocation | 
| Change in waist-hip-ratio | Waist-hip-ration will be calculated by the measured waist and hip circumference | Change from baseline at 3 months and 6 months post allocation | 
| Change in blood glucose | Point of care testing of blood for glucose | Change from baseline at 3 months and 6 months post allocation | 
| Change in blood total cholesterol | Point of care testing of blood for total cholesterol | Change from baseline at 3 months and 6 months post allocation | 
| Change in blood urate | Point of care testing of blood for urate | Change from baseline at 3 months and 6 months post allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health coaching, Health promoting behaviour, Cardiometabolic disease, Middle-aged