NCT05284162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

February 27, 2022

Last Update Submit

March 8, 2022

Conditions

CoachingCardiovascular DiseasesMetabolic Diseases

Keywords

Health coachingHealth promoting behaviourCardiometabolic diseaseMiddle-aged

Outcome Measures

Primary Outcomes (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

    Change from baseline at 3 months and 6 months post allocation

Secondary Outcomes (13)

  • Change in cardiometabolic risk

    Change from baseline at 3 months and 6 months post allocation

  • Change in stroke risk

    Change from baseline at 3 months and 6 months post allocation

  • Change in self-efficacy of adopting health promoting behaviours

    Change from baseline at 3 months and 6 months post allocation

  • Change in psychological distress

    Change from baseline at 3 months and 6 months post allocation

  • Change in sleep quality

    Change from baseline at 3 months and 6 months post allocation

  • +8 more secondary outcomes

Study Arms (2)

Health coaching

EXPERIMENTAL

Health coaching

Behavioral: Health coaching

Usual care

NO INTERVENTION

Usual care

Interventions

Health coachingBEHAVIORAL

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

Health coaching

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (18)

  • 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.

    PMID: 30833320BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 23894121BACKGROUND

  • 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.

    PMID: 33069326BACKGROUND

  • 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.

    PMID: 23199495BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 21177699BACKGROUND

  • 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.

    PMID: 27431356BACKGROUND

  • 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.

    PMID: 24416684BACKGROUND

  • 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.

    PMID: 25127667BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 15982194BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30596258BACKGROUND

  • 16. CheungAKY, ToriCD, LamCLK. Psychosocial correlates of medically unexplained physical symptoms in primary care settings: a cross-sectional study in Hong Kong. Hong Kong Pract 2012;34:99-105.

    BACKGROUND

  • Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.

    PMID: 16155782BACKGROUND

  • Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.

    PMID: 16807105BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehavior

Study Officials

  • Zoe Kwok

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Kwok

CONTACT

3943 9928zoekwok@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Lecturer

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 17, 2022

Study Start

April 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)