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NCT Number: NCT05444140

A Feasibility Study of a Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk

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.

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Key information

Conditions

Cardiometabolic Disease Health Coaching Middle-aged Adults Primary Prevention

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Coaching

Behavioral

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

Primary outcomes

  1. Feasibility of study

    Time frame: at baseline

    eligibility rate, enrolment rate

  2. Feasibility of study

    Time frame: at 3 months after enrolment

    adherence rate

  3. Feasibility of study

    Time frame: at 3 months after enrolment

    attrition rate

  4. Feasibility of study

    Time frame: at 6 months after enrolment

    attrition rate

  5. Intervention Acceptability

    Time frame: at 3 months after enrolment

    Participants' satisfaction survey

  6. Feasibility of outcome measures assessment

    Time frame: at baseline

    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)

  7. Feasibility of outcome measures assessment

    Time frame: at 6 months after enrolment

    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)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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