Heart Disease Risk FactorsNCT05422729
mHealth-supported Coach
A study testing mHealth-supported coaching and Conventional Health coaching in people with Heart Disease Risk Factors, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
Trial summary
A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Heart Disease Risk Factors
- What is being tested?
- mHealth-supported coaching and Conventional Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Sep 2022to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese ethnic
- able to read Chinese and communicate in Cantonese/Mandarin
- with non-laboratory IHRS score 10 or higher
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, 00000
Helen Chan, 39438099, helencyl@cuhk.edu.hk
About this study
Official title: A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk
A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.
Read the 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.
- Conditions
- Heart Disease Risk Factors
- Being tested
- mHealth-supported coaching, Conventional Health coaching
- Keywords
- Primary Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth-supported coachingBehavioural
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.
Conventional Health coachingBehavioural
Three individual consultation sessions delivered by a nurse.
| Study group | Role | What they receive |
|---|---|---|
| Personalised mHeatlh-supported coaching programme | Experimental | Three monthly individual consultation session, supported with a specific mobile application. Receives: Behavioral: mHealth-supported coaching |
| Traditional in-person health coaching programme | Active comparator | Three monthly individual consultation sessions. Receives: Behavioral: Conventional Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month post-allocation
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.
Measured: 6-month post-allocation
Secondary outcomes (18)
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.
Measured: 3-month post-allocation
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.
Measured: 6-month post-allocation
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.
Measured: 3-month post-allocation
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.
Measured: 6-month post-allocation
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.
Measured: 3-month post-allocation
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.
Measured: 6-month post-allocation
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.
Measured: 3-month post-allocation
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.
Measured: 6-month post-allocation
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.
Measured: Between baseline and 3-month post-allocation
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.
Measured: Between 3-month and 6-month post-allocation
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.
Measured: Between baseline and 3-month post-allocation
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.
Measured: Between 3-month and 6-month post-allocation
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.
Measured: Between baseline and 3-month post-allocation
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.
Measured: Between 3-month and 6-month post-allocation
Change in Fasting blood glucose
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Measured: Between baseline and 3-month post-allocation
Change in Fasting blood glucose
Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Measured: Between 3-month and 6-month post-allocation
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.
Measured: Between baseline and 3-month post-allocation
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.
Measured: Between 3-month and 6-month post-allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start5 Sep 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion4 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Health Bureau, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Helen YL Chan, Chinese University of Hong Kong
- Investigators
- Helen Y Chan, Ph.D, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422729
- Sponsor's protocol ID
- 05200218
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk
- ClinicalTrials.gov ID
- NCT05422729
- Acronym / sponsor ID
- 05200218
- Conditions
- Heart Disease Risk Factors
- Keywords
- Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Food and Health Bureau, Hong KongOther government
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 4 Sep 2024 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised mHeatlh-supported coaching programme | Experimental | Behavioral: mHealth-supported coachingThree monthly individual consultation session, supported with a specific mobile application. |
| Traditional in-person health coaching programme | Active comparator | Behavioral: Conventional Health coachingThree monthly individual consultation sessions. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese ethnic
- able to read Chinese and communicate in Cantonese/Mandarin
- with non-laboratory IHRS score 10 or higher
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth-supported coachingThe 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. | Behavioural | Personalised mHeatlh-supported coaching programme |
| Conventional Health coachingThree individual consultation sessions delivered by a nurse. | Behavioural | Traditional in-person health coaching programme |
Primary outcome
Health-promoting behaviours
Time frame: 3-month post-allocation
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
Time frame: 6-month post-allocation
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.
18 secondary outcomes
Self-efficacy of adopting health-promoting behaviours
Time frame: 3-month post-allocation
Self-efficacy
Time frame: 6-month post-allocation
INTERHEART risk score
Time frame: 3-month post-allocation
INTERHEART risk score
Time frame: 6-month post-allocation
automatic retinal image analysis
Time frame: 3-month post-allocation
automatic retinal image analysis (ARIA)
Time frame: 6-month post-allocation
Psychological distress
Time frame: 3-month post-allocation
Psychological distress
Time frame: 6-month post-allocation
Change in Blood pressure
Time frame: Between baseline and 3-month post-allocation
Change in Blood pressure
Time frame: Between 3-month and 6-month post-allocation
Change in Body mass index (BMI)
Time frame: Between baseline and 3-month post-allocation
Change in Body mass index(BMI)
Time frame: Between 3-month and 6-month post-allocation
Change in Waist-hip ratio (WHR)
Time frame: Between baseline and 3-month post-allocation
Change in Waist-hip ratio (WHR)
Time frame: Between 3-month and 6-month post-allocation
Change in Fasting blood glucose
Time frame: Between baseline and 3-month post-allocation
Change in Fasting blood glucose
Time frame: Between 3-month and 6-month post-allocation
Change in Blood lipid profile
Time frame: Between baseline and 3-month post-allocation
Change in Blood lipid profile
Time frame: Between 3-month and 6-month post-allocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Y Chan, Ph.D principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth-supported coaching and Conventional Health coaching in people with Heart Disease Risk Factors, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Y Chan, Ph.D (+85239438099, helencyl@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-promoting behaviours (time frame: 3-month post-allocation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.