NCT05444140

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 27, 2022

Last Update Submit

June 28, 2022

Conditions

Keywords

cardiometabolic diseasefeasibility studyhealth coachingmiddle-aged adultsprimary prevention

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Health coaching

Behavioral: Health coaching

Interventions

Health coachingBEHAVIORAL

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

Experimental group

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 16 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, 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Kwok ZC, Tam HL, Zee BC, Lo SW, Tang FW, Tao A, Chan HY. A protection motivation theory-guided telehealth coaching program for middle-aged adults with cardiometabolic risk: A feasibility trial. BMC Public Health. 2025 Mar 24;25(1):1120. doi: 10.1186/s12889-025-22238-w.

Study Officials

  • Zoe Kwok

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 5, 2022

Study Start

April 1, 2021

Primary Completion

November 13, 2021

Study Completion

November 13, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations