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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental group
Health coaching
Behavioral: Health coaching
The health coaching programme includes four monthly health coaching sessions for three months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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