- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444140
A Feasibility Study of a Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk
June 28, 2022 updated by: Zoe Ching Man Kwok, Chinese University of Hong Kong
A Theory-guided Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk to Improve Health Promoting Behaviours: a Feasibility Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
Health coaching
|
The health coaching programme includes four monthly health coaching sessions for three months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of study
Time Frame: at baseline
|
eligibility rate, enrolment rate
|
at baseline
|
Feasibility of study
Time Frame: at 3 months after enrolment
|
adherence rate
|
at 3 months after enrolment
|
Feasibility of study
Time Frame: at 3 months after enrolment
|
attrition rate
|
at 3 months after enrolment
|
Feasibility of study
Time Frame: at 6 months after enrolment
|
attrition rate
|
at 6 months after enrolment
|
Intervention Acceptability
Time Frame: at 3 months after enrolment
|
Participants' satisfaction survey
|
at 3 months after enrolment
|
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)
|
at baseline
|
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)
|
at 6 months after enrolment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2021
Primary Completion (ACTUAL)
November 13, 2021
Study Completion (ACTUAL)
November 13, 2021
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (ACTUAL)
July 5, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 5, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Health coaching midlife pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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