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mHealth-supported Coach

Primary Purpose

Heart Disease Risk Factors

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
mHealth-supported coaching
Conventional Health coaching
Sponsored by
Food and Health Bureau, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Disease Risk Factors focused on measuring Primary Health Care

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chinese ethnic
  • able to read Chinese and communicate in Cantonese/Mandarin
  • with non-laboratory IHRS score 10 or higher

Exclusion Criteria:

  • mentally incompetent
  • previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
  • with eye or retinal disease
  • with terminal disease with an expected life expectancy less than six months
  • being pregnant
  • have enrolled in other lifestyle-based or exercise-based projects
  • do have mobile devices or internet service to access the mobile application

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalised mHeatlh-supported coaching programme

Traditional in-person health coaching programme

Arm Description

Three monthly individual consultation session, supported with a specific mobile application.

Three monthly individual consultation sessions.

Outcomes

Primary Outcome Measures

Health-promoting behaviours
Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.
Health-promoting behaviours
Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.

Secondary Outcome Measures

Self-efficacy of adopting health-promoting behaviours
The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
Self-efficacy
The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
INTERHEART risk score
The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.
INTERHEART risk score
The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.
automatic retinal image analysis
Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
automatic retinal image analysis (ARIA)
Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
Psychological distress
The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.
Psychological distress
The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.
Change in Blood pressure
Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.
Change in Blood pressure
Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.
Change in Body mass index (BMI)
BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
Change in Body mass index(BMI)
BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
Change in Waist-hip ratio (WHR)
WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.
Change in Waist-hip ratio (WHR)
WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.
Change in Fasting blood glucose
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Change in Fasting blood glucose
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Change in Blood lipid profile
The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Change in Blood lipid profile
The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.

Full Information

First Posted
June 8, 2022
Last Updated
August 18, 2023
Sponsor
Food and Health Bureau, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05422729
Brief Title
mHealth-supported Coach
Official Title
A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Food and Health Bureau, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.
Detailed Description
Aim: To evaluate the effects of a personalised mHealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care. Design: A 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted. Participants: People who aged between 40 and 64, mentally competent, have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher, communicable in Chinese and free from stroke and transient ischemic attack (TIA) or other cardiovascular disease will be eligible to the study. A total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group. Intervention: A theory-based mHealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease Risk Factors
Keywords
Primary Health Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalised mHeatlh-supported coaching programme
Arm Type
Experimental
Arm Description
Three monthly individual consultation session, supported with a specific mobile application.
Arm Title
Traditional in-person health coaching programme
Arm Type
Active Comparator
Arm Description
Three monthly individual consultation sessions.
Intervention Type
Behavioral
Intervention Name(s)
mHealth-supported coaching
Intervention Description
The intervention includes two components. Three individual consultation sessions based on a health coaching protocol developed by a multidisciplinary team. A mobile application provides educational information about healthy lifestyles, knowledge quizzes, telemonitoring function and virtual platform for sharing.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Health coaching
Intervention Description
Three individual consultation sessions delivered by a nurse.
Primary Outcome Measure Information:
Title
Health-promoting behaviours
Description
Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.
Time Frame
3-month post-allocation
Title
Health-promoting behaviours
Description
Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.
Time Frame
6-month post-allocation
Secondary Outcome Measure Information:
Title
Self-efficacy of adopting health-promoting behaviours
Description
The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
Time Frame
3-month post-allocation
Title
Self-efficacy
Description
The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
Time Frame
6-month post-allocation
Title
INTERHEART risk score
Description
The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.
Time Frame
3-month post-allocation
Title
INTERHEART risk score
Description
The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.
Time Frame
6-month post-allocation
Title
automatic retinal image analysis
Description
Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
Time Frame
3-month post-allocation
Title
automatic retinal image analysis (ARIA)
Description
Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
Time Frame
6-month post-allocation
Title
Psychological distress
Description
The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.
Time Frame
3-month post-allocation
Title
Psychological distress
Description
The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.
Time Frame
6-month post-allocation
Title
Change in Blood pressure
Description
Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.
Time Frame
Between baseline and 3-month post-allocation
Title
Change in Blood pressure
Description
Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.
Time Frame
Between 3-month and 6-month post-allocation
Title
Change in Body mass index (BMI)
Description
BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
Time Frame
Between baseline and 3-month post-allocation
Title
Change in Body mass index(BMI)
Description
BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
Time Frame
Between 3-month and 6-month post-allocation
Title
Change in Waist-hip ratio (WHR)
Description
WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.
Time Frame
Between baseline and 3-month post-allocation
Title
Change in Waist-hip ratio (WHR)
Description
WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.
Time Frame
Between 3-month and 6-month post-allocation
Title
Change in Fasting blood glucose
Description
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Time Frame
Between baseline and 3-month post-allocation
Title
Change in Fasting blood glucose
Description
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Time Frame
Between 3-month and 6-month post-allocation
Title
Change in Blood lipid profile
Description
The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Time Frame
Between baseline and 3-month post-allocation
Title
Change in Blood lipid profile
Description
The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Time Frame
Between 3-month and 6-month post-allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese ethnic able to read Chinese and communicate in Cantonese/Mandarin with non-laboratory IHRS score 10 or higher Exclusion Criteria: mentally incompetent previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation with eye or retinal disease with terminal disease with an expected life expectancy less than six months being pregnant have enrolled in other lifestyle-based or exercise-based projects do have mobile devices or internet service to access the mobile application
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Y Chan, Ph.D
Phone
+85239438099
Email
helencyl@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Y Chan, Ph.D
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Chan
Phone
39438099
Email
helencyl@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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mHealth-supported Coach

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