A Feasibility Study of a Health Coaching Programme for 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. Health coaching, a process of goal-oriented and client-centered partnership that is health-focus and through client enlightenment and empowerment, are generally effective for chronic disease management and prevention of complication. However, there is inconclusive result on the effects of health coaching in the primary prevention of cardiometabolic diseases. Therefore, this study aimed to assess the feasibility and acceptability of a theory-guided health coaching programme for middle-aged adults with cardiometabolic risk.

Detailed Description
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A single group pretest-posttest feasibility study was conducted. The health coaching programme included four monthly health coaching sessions for three months. Feasibility of the study was measured by eligibility rate, enrollment rate, adherence rate, and attrition rate. Intervention acceptability was measured by satisfactory survey after completion of health coaching intervention. Feasibility of outcome measures was measured by the completion of outcome measures assessment at baseline and 6 months after enrollment.

Official Title
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A Theory-guided Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk to Improve Health Promoting Behaviours: a Feasibility Study

Conditions
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Cardiometabolic Disease, Health Coaching, Middle-aged Adults, Primary Prevention

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 16 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, chronic renal failure and diabetes; 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Health coaching | Behavioral: Health coaching<br>* The health coaching programme includes four monthly health coaching sessions for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study | eligibility rate, enrolment rate | at baseline | 
| Feasibility of study | adherence rate | at 3 months after enrolment | 
| Feasibility of study | attrition rate | at 3 months after enrolment | 
| Feasibility of study | attrition rate | at 6 months after enrolment | 
| Intervention Acceptability | Participants' satisfaction survey | at 3 months after enrolment | 
| Feasibility of outcome measures assessment | completion rate of a battery of outcome measures assessment (including (1) health promoting behaviours measures using Health Promoting Lifestyle Profile II (HPLP II); (2) cardiometabolic risk measured using non-laboratory INTERHEART risk score and the Automatic Retinal Image Analysis (ARIA)-stroke model; (3) self-efficacy of adopting health-promoting behaviours measured using Diabetes Mellitus Type II Self Efficacy Scale; (4) psychological distress measured using the Chinese version of the shorter version of Depression Anxiety Stress Scales (DASS); (5) sleep quality measured using the Chinese version of the Pittsburg Sleep Quality Index; (6) physical activity level measured using the International Physical Activity Questionnaire-Chinese (IPAQ-C); and (7) physiological parameters, including blood pressure, body mass index (BMI), waist-hip-ratio (WHR) and point of care blood test for glucose, lipid and urate level) | at baseline | 
| Feasibility of outcome measures assessment | completion rate of a battery of outcome measures assessment (including (1) health promoting behaviours measures using Health Promoting Lifestyle Profile II (HPLP II); (2) cardiometabolic risk measured using non-laboratory INTERHEART risk score and the Automatic Retinal Image Analysis (ARIA)-stroke model; (3) self-efficacy of adopting health-promoting behaviours measured using Diabetes Mellitus Type II Self Efficacy Scale; (4) psychological distress measured using the Chinese version of the shorter version of Depression Anxiety Stress Scales (DASS); (5) sleep quality measured using the Chinese version of the Pittsburg Sleep Quality Index; (6) physical activity level measured using the International Physical Activity Questionnaire-Chinese (IPAQ-C); and (7) physiological parameters, including blood pressure, body mass index (BMI), waist-hip-ratio (WHR) and point of care blood test for glucose, lipid and urate level) | at 6 months after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiometabolic disease, feasibility study, health coaching, middle-aged adults, primary prevention