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CoachingNCT05284162

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

A study testing Health coaching in people with Coaching and Cardiovascular Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 64 yearsHealthy volunteers can take part
What is being tested?
Health coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteHong Kong
Study dates
1 Apr 2021to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting
  • The Chinese University of Hong Kong

    Hong Kong

    Zoe Kwok

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Health coaching
Keywords
Health coaching, Health promoting behaviour, Cardiometabolic disease, Middle-aged
Medical subject headings
Cardiovascular Diseases, Metabolic Diseases, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health coachingBehavioural

    The health coaching program includes four monthly health coaching sessions for three months.

Study groups in NCT05284162
Study groupRoleWhat they receive
Health coachingExperimentalHealth coaching
Receives: Behavioral: Health coaching
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline at 3 months and 6 months post allocation

Secondary outcomes (13)
  1. Change in cardiometabolic risk

    Non-laboratory INTERHEART Risk Score (IHRS) assess the risk of cardiometabolic disease

    Measured: Change from baseline at 3 months and 6 months post allocation

  2. Change in stroke risk

    Automatic retinal image analysis (ARIA)-stroke will be used to quantify stroke risk

    Measured: Change from baseline at 3 months and 6 months post allocation

  3. 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

    Measured: Change from baseline at 3 months and 6 months post allocation

  4. 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

    Measured: Change from baseline at 3 months and 6 months post allocation

  5. Change in sleep quality

    The Chinese version of the Pittsburg Sleep Quality Index developed by Buysse and team in 1988 will be used

    Measured: Change from baseline at 3 months and 6 months post allocation

  6. 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

    Measured: Change from baseline at 3 months and 6 months post allocation

  7. Change in systolic blood pressure

    Blood pressure measurement using an electronic sphygmomanometer

    Measured: Change from baseline at 3 months and 6 months post allocation

  8. Change in diastolic blood pressure

    Blood pressure measurement using an electronic sphygmomanometer

    Measured: Change from baseline at 3 months and 6 months post allocation

  9. Change in Body Mass Index

    Body Mass Index will be calculated by the measured height and weight

    Measured: Change from baseline at 3 months and 6 months post allocation

  10. Change in waist-hip-ratio

    Waist-hip-ration will be calculated by the measured waist and hip circumference

    Measured: Change from baseline at 3 months and 6 months post allocation

  11. Change in blood glucose

    Point of care testing of blood for glucose

    Measured: Change from baseline at 3 months and 6 months post allocation

  12. Change in blood total cholesterol

    Point of care testing of blood for total cholesterol

    Measured: Change from baseline at 3 months and 6 months post allocation

  13. Change in blood urate

    Point of care testing of blood for urate

    Measured: Change from baseline at 3 months and 6 months post allocation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start1 Apr 2021
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284162
Sponsor's protocol ID
Health coaching midlife CMD
Status last verified
Mar 2022
First submitted
27 Feb 2022
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang D, Tang X, Shen P, Si Y, Liu X, Xu Z, Wu J, Zhang J, Lu P, Lin H, Gao P. Multimorbidity of cardiometabolic diseases: prevalence and risk for mortality from one million Chinese adults in a longitudinal cohort study. BMJ Open. 2019 Mar 3;9(3):e024476. doi: 10.1136/bmjopen-2018-024476.

    PubMed 30833320
  • 2. Centre of Health Protection. Death rates by leading causes of death, 2001-2019. Hong Kong SAR government: 2020.

  • Guo F, Moellering DR, Garvey WT. The progression of cardiometabolic disease: validation of a new cardiometabolic disease staging system applicable to obesity. Obesity (Silver Spring). 2014 Jan;22(1):110-8. doi: 10.1002/oby.20585. Epub 2013 Sep 5.

    PubMed 23894121
  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

    PubMed 33069326
  • Kaffashian S, Dugravot A, Brunner EJ, Sabia S, Ankri J, Kivimaki M, Singh-Manoux A. Midlife stroke risk and cognitive decline: a 10-year follow-up of the Whitehall II cohort study. Alzheimers Dement. 2013 Sep;9(5):572-9. doi: 10.1016/j.jalz.2012.07.001. Epub 2012 Nov 28.

    PubMed 23199495
  • 6. Centre for Health Protection. Population Health Survey 2014/2015. Hong Kong SAR Government.: 2017.

  • McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, Dans AL, Gerstein HC, Teo K, Anand SS; INTERHEART Investigators. Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J. 2011 Mar;32(5):581-9. doi: 10.1093/eurheartj/ehq448. Epub 2010 Dec 22.

    PubMed 21177699
  • O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.

    PubMed 27431356
  • Wolever RQ, Simmons LA, Sforzo GA, Dill D, Kaye M, Bechard EM, Southard ME, Kennedy M, Vosloo J, Yang N. A Systematic Review of the Literature on Health and Wellness Coaching: Defining a Key Behavioral intervention in Healthcare. Glob Adv Health Med. 2013 Jul;2(4):38-57. doi: 10.7453/gahmj.2013.042.

    PubMed 24416684
  • Kivela K, Elo S, Kyngas H, Kaariainen M. The effects of health coaching on adult patients with chronic diseases: a systematic review. Patient Educ Couns. 2014 Nov;97(2):147-57. doi: 10.1016/j.pec.2014.07.026. Epub 2014 Aug 1.

    PubMed 25127667
  • 11. UCSF Center for Excellence in Primary Care. Health coach curriculum. University of California: 2014.

  • 12. WalkerSN, Hill-PolereckyDM. Psychometric evaluation of the Health-Promoting Lifestyle Profile II. Unpublished manuscript, University of Nebraska Medical Center 1996.

  • Lee RL, Loke AJ. Health-promoting behaviors and psychosocial well-being of university students in Hong Kong. Public Health Nurs. 2005 May-Jun;22(3):209-20. doi: 10.1111/j.0737-1209.2005.220304.x.

    PubMed 15982194
  • 14. ZeeB, LeeJ, LiQ, MokV, KongA, ChiangL, et al. Stroke risk assessment for the community by automatic retinal image analysis using fundus photograph. Qual Prim Care 2016;24:114-24.

  • Brouwer-Goossensen D, van Genugten L, Lingsma HF, Dippel DWJ, Koudstaal PJ, den Hertog HM. Self-efficacy for health-related behaviour change in patients with TIA or minor ischemic stroke. Psychol Health. 2018 Dec;33(12):1490-1501. doi: 10.1080/08870446.2018.1508686. Epub 2018 Dec 30.

    PubMed 30596258

Questions about this trial

What is this clinical trial studying?

A study testing Health coaching in people with Coaching and Cardiovascular Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zoe Kwok (3943 9928, zoekwok@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in health promoting behaviours (time frame: Change from baseline at 3 months and 6 months post allocation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284162, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.

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