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

Primary Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444140
• Other study ID #: Health coaching midlife pilot
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: November 13, 2021

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 13, 2021
• Est. primary completion date: November 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Disease
• Primary Prevention

Intervention

Behavioral:
• Health coaching
The health coaching programme includes four monthly health coaching sessions for three months.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study	eligibility rate, enrolment rate	at baseline
Primary	Feasibility of study	adherence rate	at 3 months after enrolment
Primary	Feasibility of study	attrition rate	at 3 months after enrolment
Primary	Feasibility of study	attrition rate	at 6 months after enrolment
Primary	Intervention Acceptability	Participants' satisfaction survey	at 3 months after enrolment
Primary	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
Primary	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