Clinical trial NCT05284162: Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk
Official title: Effects of a Theory-guided Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coaching
Cardiovascular Diseases
Metabolic Diseases
Keywords: Health coaching
Health promoting behaviour
Cardiometabolic disease
Middle-aged
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in health promoting behaviours
timeFrame: Change from baseline at 3 months and 6 months post allocation
Secondary outcomes:
measure: Change in cardiometabolic risk
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in stroke risk
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in self-efficacy of adopting health promoting behaviours
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in psychological distress
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in sleep quality
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in physical activities
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in systolic blood pressure
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in diastolic blood pressure
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in Body Mass Index
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in waist-hip-ratio
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in blood glucose
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in blood total cholesterol
timeFrame: Change from baseline at 3 months and 6 months post allocation
measure: Change in blood urate
timeFrame: Change from baseline at 3 months and 6 months post allocation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zoe Kwok
role: PRINCIPAL_INVESTIGATOR
References:
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