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Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial
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注册号：

Registration number：

 ChiCTR2400080248 

最近更新日期：

Date of Last Refreshed on：

 2024-01-24 16:40:37 

注册时间：

Date of Registration：

 2024-01-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

Public title：

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

注册题目简写：

WeWATCH RCT

English Acronym：

WeWATCH RCT

研究课题的正式科学名称：

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

Scientific title：

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

研究课题代号(代码)：

Study subject ID：

 NA

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

NA

申请注册联系人：

Prof. Benjamin Hon-Kei Yip 

研究负责人：

Prof. Benjamin Hon-Kei Yip 

Applicant：

Prof. Benjamin Hon-Kei Yip 

Study leader：

Prof. Benjamin Hon-Kei Yip 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8455

研究负责人电话：

Study leader's
telephone：

+852 2252 8455

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 benyip@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 benyip@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 NA

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 NA

申请注册联系人通讯地址：

Room 406, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

研究负责人通讯地址：

Room 406, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

Applicant address：

Room 406, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

Study leader's address：

Room 406, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

申请注册联系人邮政编码：

Applicant postcode：

 0000

研究负责人邮政编码：

Study leader's postcode：

 0000

申请人所在单位：

JC School of Public Health and Primary Care, CUHK

Applicant's institution：

JC School of Public Health and Primary Care, CUHK

研究负责人所在单位：

JC School of Public Health and Primary Care, CUHK

Affiliation of the Leader：

JC School of Public Health and Primary Care, CUHK

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023.587

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-16 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3824

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec2@cuhk.edu.hk

研究实施负责（组长）单位：

JC School of Public Health and Primary Care, CUHK

Primary sponsor：

JC School of Public Health and Primary Care, CUHK

研究实施负责（组长）单位地址：

Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

Primary sponsor's address：

Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Hong Kong

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

JC School of Public Health and Primary Care, CUHK

具体地址：

Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

Institution
hospital：

JC School of Public Health and Primary Care, CUHK

Address：

Prince of Wales Hospital, Shatin, New Territories, HKSAR, China

经费或物资来源：

Source(s) of funding：

The Hong Kong Jockey Club Charities Trust

研究疾病：

NCDs  

Target disease：

NCDs

研究疾病代码：

NA

Target disease code：

NA

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary objectives of this RCT are to confirm: 1. The effectiveness of health coaching (HC) + health watch (HW) intervention versus waitlist group on lipid profiles, glucose level, and blood pressures, and risk of having CVD (defined by QRisk) 2. The effectiveness of the effect of HC-only intervention versus waitlist group and the effect of HW-only versus waitlist group on lipid, glucose, blood pressure, and risk of having CVD (defined by QRisk) The secondary objectives are exploratorily basis: 1. The effectiveness of the interventions listed in the primary objectives on secondary outcomes (lifestyle measures such as physical activities, food consumption, and alcohol and smoking consumptions) 2. To compare the effectiveness of combined interventions (HC + HW) versus HC-only and HW-only respectively. 3. To compare the effectiveness of HC-only vs HW-only intervention.  

Objectives of Study：

The primary objectives of this RCT are to confirm: 1. The effectiveness of health coaching (HC) + health watch (HW) intervention versus waitlist group on lipid profiles, glucose level, and blood pressures, and risk of having CVD (defined by QRisk) 2. The effectiveness of the effect of HC-only intervention versus waitlist group and the effect of HW-only versus waitlist group on lipid, glucose, blood pressure, and risk of having CVD (defined by QRisk) The secondary objectives are exploratorily basis: 1. The effectiveness of the interventions listed in the primary objectives on secondary outcomes (lifestyle measures such as physical activities, food consumption, and alcohol and smoking consumptions) 2. To compare the effectiveness of combined interventions (HC + HW) versus HC-only and HW-only respectively. 3. To compare the effectiveness of HC-only vs HW-only intervention.

药物成份或治疗方案详述：

Health coaching is defined as "the practice of health education and health promotion within a coaching context, to enhance the wellbeing of individuals and to facilitate the achievement of their health-related goals" (Palmer et al., 2003), and is considered as an integrated part of lifestyle medicine. The goal for health coaching is to facilitate individual’s behaviour changes, so that desired behaviours can be sustained and maintained (Conn & Curtain, 2019). Psychological techniques are applied in health coaching, such as transtheoretical model, goal-setting theory, motivational interviewing (MI), cognitive behavioural therapy (CBT), and etc. (Frates et al., 2011). These techniques would help reducing barriers, increasing confidence of individuals and ultimately boosting individual’s internal motivation which leads to long-term behavioural changes (Butterworth et al., 2007; Ryn, 1997). Health watch or health wearable is considered as one of the most popular gadgets available in the health market. Health watches typically consist of various health tracking features, such as fitness monitoring, heart rate (HR) and oxygen saturation (SpO2) measurement, and sleep analysis. Due to their convenience, health watches have the potential to be utilized as self-monitoring devices for individual health purposes (Reeder & David, 2016). There are limited research that asses the effectiveness of health watch on individuals’ health available, yet some has displayed the potential for health watch to influence individuals to perform healthy behaviours. A systematic review has shown that wearable devices can significantly increase physical activity level among those with chronic cardiometabolic diseases (Kirk et al., 2019). A randomized controlled trial involving 72 type 2 diabetes patients shown that the provision of an activity tracker (Fitbit) can significantly increase participants’ weekly frequency of performing moderate to vigorous level of physical activity for at least 30 minutes for 1.5 days and is able to increase participant’s daily step count for 1255 steps per days (Kooiman et al., 2018). 

Description for medicine or protocol of treatment in detail：

Health coaching is defined as "the practice of health education and health promotion within a coaching context, to enhance the wellbeing of individuals and to facilitate the achievement of their health-related goals" (Palmer et al., 2003), and is considered as an integrated part of lifestyle medicine. The goal for health coaching is to facilitate individual’s behaviour changes, so that desired behaviours can be sustained and maintained (Conn & Curtain, 2019). Psychological techniques are applied in health coaching, such as transtheoretical model, goal-setting theory, motivational interviewing (MI), cognitive behavioural therapy (CBT), and etc. (Frates et al., 2011). These techniques would help reducing barriers, increasing confidence of individuals and ultimately boosting individual’s internal motivation which leads to long-term behavioural changes (Butterworth et al., 2007; Ryn, 1997). Health watch or health wearable is considered as one of the most popular gadgets available in the health market. Health watches typically consist of various health tracking features, such as fitness monitoring, heart rate (HR) and oxygen saturation (SpO2) measurement, and sleep analysis. Due to their convenience, health watches have the potential to be utilized as self-monitoring devices for individual health purposes (Reeder & David, 2016). There are limited research that asses the effectiveness of health watch on individuals’ health available, yet some has displayed the potential for health watch to influence individuals to perform healthy behaviours. A systematic review has shown that wearable devices can significantly increase physical activity level among those with chronic cardiometabolic diseases (Kirk et al., 2019). A randomized controlled trial involving 72 type 2 diabetes patients shown that the provision of an activity tracker (Fitbit) can significantly increase participants’ weekly frequency of performing moderate to vigorous level of physical activity for at least 30 minutes for 1.5 days and is able to increase participant’s daily step count for 1255 steps per days (Kooiman et al., 2018). 

纳入标准：

Inclusion criteria

排除标准：

1) Not aged between 35 – 59. 2) With doctor-diagnosed chronic diseases and require medication (including diabetes, hypertension, cardiovascular diseases, chronic obstructive pulmonary diseases, depression, autoimmune diseases, and cancer). 3) In the waiting list for follow-up healthcare services in the public or private sector because of the listed chronic diseases above. 4) A member of district health centre. 5) Those who cannot provide consent. 6) Pregnant woman. 7) Does not understand Cantonese.

Exclusion criteria：

1) Not aged between 35 – 59. 2) With doctor-diagnosed chronic diseases and require medication (including diabetes, hypertension, cardiovascular diseases, chronic obstructive pulmonary diseases, depression, autoimmune diseases, and cancer). 3) In the waiting list for follow-up healthcare services in the public or private sector because of the listed chronic diseases above. 4) A member of district health centre. 5) Those who cannot provide consent. 6) Pregnant woman. 7) Does not understand Cantonese.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2024-09-30 00:00:00

干预措施：

Interventions：

组别：

Health coaching + Smart watch intervention group

样本量：

 500

Group：

Health coaching + Smart watch intervention group

Sample size：

干预措施：

Participants receiving the "health coaching" intervention will match with a personal health coach. After completing the blood pressure measurement and blood test, the health coach will first assess the lifestyle practice of the participant. A tailor-made action plan with targets will then be set. The participant will only need to carry out the action plan upon consensus with the health coach. After that, the action plan will be adjusted according to the participant’s compliance and achievement. The health coach will communicate with the participant regularly (in the form of group/individual, by face-to-face or digital meeting) to provide health coaching. Participants receiving the "health watch" intervention will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure).

干预措施代码：

Intervention：

Participants receiving the "health coaching" intervention will match with a personal health coach. After completing the blood pressure measurement and blood test, the health coach will first assess the lifestyle practice of the participant. A tailor-made action plan with targets will then be set. The participant will only need to carry out the action plan upon consensus with the health coach. After that, the action plan will be adjusted according to the participant’s compliance and achievement. The health coach will communicate with the participant regularly (in the form of group/individual, by face-to-face or digital meeting) to provide health coaching. Participants receiving the "health watch" intervention will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure).

Intervention code：

组别：

Health coaching intervention group

样本量：

 500

Group：

Health coaching intervention group

Sample size：

干预措施：

Participants receiving the "health coaching" intervention will match with a personal health coach. After completing the blood pressure measurement and blood test, the health coach will first assess the lifestyle practice of the participant. A tailor-made action plan with targets will then be set. The participant will only need to carry out the action plan upon consensus with the health coach. After that, the action plan will be adjusted according to the participant’s compliance and achievement. The health coach will communicate with the participant regularly (in the form of group/individual, by face-to-face or digital meeting) to provide health coaching.

干预措施代码：

Intervention：

Participants receiving the "health coaching" intervention will match with a personal health coach. After completing the blood pressure measurement and blood test, the health coach will first assess the lifestyle practice of the participant. A tailor-made action plan with targets will then be set. The participant will only need to carry out the action plan upon consensus with the health coach. After that, the action plan will be adjusted according to the participant’s compliance and achievement. The health coach will communicate with the participant regularly (in the form of group/individual, by face-to-face or digital meeting) to provide health coaching.

Intervention code：

组别：

Smart watch intervention group

样本量：

 500

Group：

Smart watch intervention group

Sample size：

干预措施：

Participants receiving the "health watch" intervention will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure).

干预措施代码：

Intervention：

Participants receiving the "health watch" intervention will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure).

Intervention code：

组别：

Waitlist control group

样本量：

 500

Group：

Waitlist control group

Sample size：

干预措施：

Subjects in this arm will have to wait for 6 months after randomization before receiving health coaching intervention and health watch intervention for 6 months. This group will be served as the control group to the trial.

干预措施代码：

Intervention：

Subjects in this arm will have to wait for 6 months after randomization before receiving health coaching intervention and health watch intervention for 6 months. This group will be served as the control group to the trial.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 The Christian Family Service Centre 

单位级别：

 Non-governmental organization, Community Health Service Center 

Institution
hospital：

The Christian Family Service Centre

Level of the institution：

Non-governmental organization, Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 St James' Settlement 

单位级别：

 Non-governmental organization, Community Health Service Center 

Institution
hospital：

St James' Settlement

Level of the institution：

Non-governmental organization, Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 The United Christian Nethersole Community Health Service 

单位级别：

 Non-governmental organization, Community Health Service Center 

Institution
hospital：

The United Christian Nethersole Community Health Service

Level of the institution：

Non-governmental organization, Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 Hong Kong Young Women’s Christian Association 

单位级别：

 Non-governmental organization, Community Health Service Center 

Institution
hospital：

Hong Kong Young Women’s Christian Association

Level of the institution：

Non-governmental organization, Community Health Service Center

测量指标：

Outcomes：

指标中文名：

Blood biochemical (FBG, TC, HDL, LDL, TG)

指标类型：

主要指标

Outcome：

Blood biochemical (FBG, TC, HDL, LDL, TG)

Type：

Primary indicator

测量时间点：

Baseline and 6 months

测量方法：

Blood test

Measure time point of outcome：

Baseline and 6 months

Measure method：

Blood test

指标中文名：

Blood pressure

指标类型：

主要指标

Outcome：

Blood pressure

Type：

Primary indicator

测量时间点：

Baseline and 6 months

测量方法：

Microlife WatchBP Office 2G

Measure time point of outcome：

Baseline and 6 months

Measure method：

Microlife WatchBP Office 2G

指标中文名：

Heart rate, Steps count, Frequency of Physical activity, Sleeping quality score

指标类型：

主要指标

Outcome：

Heart rate, Steps count, Frequency of Physical activity, Sleeping quality score

Type：

Primary indicator

测量时间点：

Within 6 months of the intervention period

测量方法：

Measured by the health wearable (HuaWei Watch Fit 2)

Measure time point of outcome：

Within 6 months of the intervention period

Measure method：

Measured by the health wearable (HuaWei Watch Fit 2)

指标中文名：

Alcohol use (by AUDIT-C)

指标类型：

次要指标

Outcome：

Alcohol use (by AUDIT-C)

Type：

Secondary indicator

测量时间点：

Baseline and 6 months

测量方法：

Questionnaire

Measure time point of outcome：

Baseline and 6 months

Measure method：

Questionnaire

指标中文名：

Diet

指标类型：

次要指标

Outcome：

Diet

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Physical activity level (by IPAQ-SF)

指标类型：

次要指标

Outcome：

Physical activity level (by IPAQ-SF)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Health-related Quality of life (By EQ5D)

指标类型：

次要指标

Outcome：

Health-related Quality of life (By EQ5D)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Sleep quality and disturbances (By PSQI)

指标类型：

次要指标

Outcome：

Sleep quality and disturbances (By PSQI)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Perceived stress (By PSS-10)

指标类型：

次要指标

Outcome：

Perceived stress (By PSS-10)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Anxiety (By GAD-7)

指标类型：

次要指标

Outcome：

Anxiety (By GAD-7)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Depression (By PHQ-9)

指标类型：

次要指标

Outcome：

Depression (By PHQ-9)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Satisfactory of life

指标类型：

次要指标

Outcome：

Satisfactory of life

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Social media addiction (BSMAS)

指标类型：

次要指标

Outcome：

Social media addiction (BSMAS)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Loneliness (By 6-item De Jong Gierveld Loneliness Scale)

指标类型：

次要指标

Outcome：

Loneliness (By 6-item De Jong Gierveld Loneliness Scale)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Self-efficacy (By 10-item General Self Efficacy Scale)

指标类型：

次要指标

Outcome：

Self-efficacy (By 10-item General Self Efficacy Scale)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

e-health literacy (By 8-item eHealth Literacy Scale)

指标类型：

次要指标

Outcome：

e-health literacy (By 8-item eHealth Literacy Scale)

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

指标中文名：

Body composition

指标类型：

次要指标

Outcome：

Body composition

Type：

Secondary indicator

测量时间点：

Baseline and 6 months

测量方法：

Tanita RD545

Measure time point of outcome：

Baseline and 6 months

Measure method：

Tanita RD545

指标中文名：

Demographic and CVD risk exposure data

指标类型：

次要指标

Outcome：

Demographic and CVD risk exposure data

Type：

Secondary indicator

测量时间点：

Baseline, 3 months and 6 months after intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, 3 months and 6 months after intervention

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood sample

组织：

Sample Name：

Blood sample

Tissue：

NA

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

NA

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 35 岁 years
最大 Max age 59 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

2,000 subjects will be recruited into the 4-arm design of the RCT. The number of subjects in each arm will be distributed in 1:1:1:1 ratio (250 subjects for each arm). These subjects will be distributed to 7 centres out of 4 NGOs equally. Block randomization by centres will be performed to balance the number of subjects in each arm per centre. An interim analysis will then be performed to assess whether the effect of the objectives have been determined. If the effect has been determined, then the remaining 1000 participants will be randomized into the 4 groups in the same manner. If not, the control group will be taken out, so that the remaining 1000 participants will be randomized into the remaining 3 treatment arms in 1:1:1 ratio. The randomization sequence will be generated by an independent statistician.

Randomization Procedure (please state who generates the random number sequence and by what method)：

2,000 subjects will be recruited into the 4-arm design of the RCT. The number of subjects in each arm will be distributed in 1:1:1:1 ratio (250 subjects for each arm). These subjects will be distributed to 7 centres out of 4 NGOs equally. Block randomization by centres will be performed to balance the number of subjects in each arm per centre. An interim analysis will then be performed to assess whether the effect of the objectives have been determined. If the effect has been determined, then the remaining 1000 participants will be randomized into the 4 groups in the same manner. If not, the control group will be taken out, so that the remaining 1000 participants will be randomized into the remaining 3 treatment arms in 1:1:1 ratio. The randomization sequence will be generated by an independent statistician.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

The primary investigator will be blinded from the allocation. While the participants and intervention deliverers (The health coaches) will not be blinded.

Blinding：

The primary investigator will be blinded from the allocation. While the participants and intervention deliverers (The health coaches) will not be blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-01-24 16:40:13
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