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

March 8, 2022 updated by: Zoe Ching Man Kwok, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
          • Zoe Kwok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiometabolic risk
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
Blood pressure measurement using an electronic sphygmomanometer
Change from baseline at 3 months and 6 months post allocation
Change in diastolic blood pressure
Time Frame: Change from baseline at 3 months and 6 months post allocation
Blood pressure measurement using an electronic sphygmomanometer
Change from baseline at 3 months and 6 months post allocation
Change in Body Mass Index
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
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
Time Frame: Change from baseline at 3 months and 6 months post allocation
Point of care testing of blood for glucose
Change from baseline at 3 months and 6 months post allocation
Change in blood total cholesterol
Time Frame: Change from baseline at 3 months and 6 months post allocation
Point of care testing of blood for total cholesterol
Change from baseline at 3 months and 6 months post allocation
Change in blood urate
Time Frame: Change from baseline at 3 months and 6 months post allocation
Point of care testing of blood for urate
Change from baseline at 3 months and 6 months post allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Health coaching midlife CMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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