简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Personalised Lifestyle Medicine in Mid-life Project
下载XML文档

注册号：

Registration number：

 ChiCTR2400092811 

最近更新日期：

Date of Last Refreshed on：

 2024-11-25 08:45:10 

注册时间：

Date of Registration：

 2024-11-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Personalised Lifestyle Medicine in Mid-life Project

Public title：

Personalised Lifestyle Medicine in Mid-life Project

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Personalised Lifestyle Medicine in Mid-life Project

Scientific title：

Personalised Lifestyle Medicine in Mid-life Project

研究课题代号(代码)：

Study subject ID：

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：

申请注册联系人：

Tang Tak Ka 

研究负责人：

Prof. Samuel Wong 

Applicant：

Tang Tak Ka 

Study leader：

Prof. Samuel Wong 

申请注册联系人电话：

Applicant telephone：

 +852 2609 5117

研究负责人电话：

Study leader's
telephone：

+852 2252 8784

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：

 tktang@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 421, Lek Yuen Health Centre, Sha Tin, Hong Kong

研究负责人通讯地址：

2/F, JC School of Public Health and Parimary Care, Prince Wales Hospital, Sha Tin, Hong K

Applicant address：

Room 421, Lek Yuen Health Centre, Sha Tin, Hong Kong

Study leader's address：

2/F, JC School of Public Health and Parimary Care, Prince Wales Hospital, Sha Tin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Applicant's institution：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Affiliation of the Leader：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

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：

 2022.577

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 Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-19 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 3503 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

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)：

China

具体地址：

Hong Kong

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：

The Hong Kong Jockey Club Charities Trust

Source(s) of funding：

The Hong Kong Jockey Club Charities Trust

研究疾病：

Chronic diseases  

Target disease：

Chronic diseases

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The specific objectives are: 1. Assessing the undiagnosed hypertension and diabetes mellites (DM) prevalence among those aged 35-59 of the Hong Kong population. 2. Using a cohort approach, to provide intervention to at-risk subjects and change their lifestyle behaviour and biometric measures in short term (6 months). 3. Establish a cohort with longer follow up time (10 years) to facilitate the development of a Hong Kong adapted prediction model of cardiovascular disease (CVD). 4. Assessing the cost-effectiveness of the intervention.  

Objectives of Study：

The specific objectives are: 1. Assessing the undiagnosed hypertension and diabetes mellites (DM) prevalence among those aged 35-59 of the Hong Kong population. 2. Using a cohort approach, to provide intervention to at-risk subjects and change their lifestyle behaviour and biometric measures in short term (6 months). 3. Establish a cohort with longer follow up time (10 years) to facilitate the development of a Hong Kong adapted prediction model of cardiovascular disease (CVD). 4. Assessing the cost-effectiveness of the intervention.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

This project targets middle-aged people without NCDs but with higher NCD risk in the future. Participants will first be screened by a screening survey that can identify their risk of having NCD, which includes questions regarding lifestyles practice, chronic diseases status, and diet. Participants with a higher risk of having NCDs will then receive a blood pressure measurement and blood test. If the participant is not found reaching the diagnostic level of diabetes or hypertension, he/she will participate in a series of activities ("the scheme") and follow up with another blood pressure measurement, blood test, and questionnaire after 6 months. In addition, participants will be invited to do a voluntary questionnaire after 3 months from the first coaching section. The following are the details of "the scheme". 1. Health coach Participants in "the scheme" 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. 2. Health watch Participants in "the scheme" will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure). 3. "CORE" activity Participants in "the scheme" will be assigned to one criteria of the "CORE" activity, which includes the following: 1) sports; 2) mental health; and 3) nutrition. The "CORE" activity is provided by the NGOs. Apart from the criteria assigned, the participant can register to join the other criteria. 

纳入标准：

Inclusion criteria

排除标准：

1) Those who cannot provide consent. 2) Pregnant women. 3) Do not understand Cantonese.

Exclusion criteria：

1) Those who cannot provide consent. 2) Pregnant women. 3) Do not understand Cantonese.

研究实施时间：

Study execute time：

从 From 2022-02-14 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-14 00:00:00 至 To 2025-01-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 20000

Group：

Intervention group

Sample size：

干预措施：

This project targets middle-aged people without NCDs but with higher NCD risk in the future. Participants will first be screened by a screening survey that can identify their risk of having NCD, which includes questions regarding lifestyles practice, chronic diseases status, and diet. Participants with a higher risk of having NCDs will then receive a blood pressure measurement and blood test. If the participant is not found reaching the diagnostic level of diabetes or hypertension, he/she will participate in a series of activities ("the scheme") and follow up with another blood pressure measurement, blood test, and questionnaire after 6 months. In addition, participants will be invited to do a voluntary questionnaire after 3 months from the first coaching section. The following are the details of "the scheme". 1. Health coach Participants in "the scheme" 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. 2. Health watch Participants in "the scheme" will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure). 3. "CORE" activity Participants in "the scheme" will be assigned to one criteria of the "CORE" activity, which includes the following: 1) sports; 2) mental health; and 3) nutrition. The "CORE" activity is provided by the NGOs. Apart from the criteria assigned, the participant can register to join the other criteria.

干预措施代码：

Intervention：

This project targets middle-aged people without NCDs but with higher NCD risk in the future. Participants will first be screened by a screening survey that can identify their risk of having NCD, which includes questions regarding lifestyles practice, chronic diseases status, and diet. Participants with a higher risk of having NCDs will then receive a blood pressure measurement and blood test. If the participant is not found reaching the diagnostic level of diabetes or hypertension, he/she will participate in a series of activities ("the scheme") and follow up with another blood pressure measurement, blood test, and questionnaire after 6 months. In addition, participants will be invited to do a voluntary questionnaire after 3 months from the first coaching section. The following are the details of "the scheme". 1. Health coach Participants in "the scheme" 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. 2. Health watch Participants in "the scheme" will be provided a health watch to collect their health data (including physical activity record, heart rate, sleep, and blood pressure). 3. "CORE" activity Participants in "the scheme" will be assigned to one criteria of the "CORE" activity, which includes the following: 1) sports; 2) mental health; and 3) nutrition. The "CORE" activity is provided by the NGOs. Apart from the criteria assigned, the participant can register to join the other criteria.

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)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Christian Family Service Centre 

单位级别：

 Community Health Service Center 

Institution
hospital：

The Christian Family Service Centre

Level of the institution：

Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 St James' Settlement 

单位级别：

 Community Health Service Center 

Institution
hospital：

St James' Settlement

Level of the institution：

Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The United Christian Nethersole Community Health Service 

单位级别：

 Community Health Service Center 

Institution
hospital：

The United Christian Nethersole Community Health Service

Level of the institution：

Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Hong Kong Young Women’s Christian Association 

单位级别：

 Community Health Service Center 

Institution
hospital：

Hong Kong Young Women’s Christian Association

Level of the institution：

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：

次要指标

Outcome：

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

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

Blood test

指标中文名：

Blood pressure

指标类型：

次要指标

Outcome：

Blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

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

指标类型：

次要指标

Outcome：

Heart rate, Steps count, Frequency of Physical activity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

Measured by the health wearable (HuaWei Watch Fit 2)

指标中文名：

QRisk-3 risk factors

指标类型：

次要指标

Outcome：

QRisk-3 risk factors

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

Questionnaire

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：

测量方法：

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：

测量方法：

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：

测量方法：

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

Questionnaire

指标中文名：

Health-related Quality of life (By SF12)

指标类型：

次要指标

Outcome：

Health-related Quality of life (By SF12)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

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：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

Tanita RD545

指标中文名：

Pulse wave velocity

指标类型：

次要指标

Outcome：

Pulse wave velocity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

SMT Vicorder

指标中文名：

Life Simple 7 score

指标类型：

主要指标

Outcome：

Life Simple 7 score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

questionnaire

指标中文名：

Life Essential 8 score

指标类型：

次要指标

Outcome：

Life Essential 8 score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and 6 months

Measure method：

questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

Blood

Tissue：

Blood sample

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

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）：

Not necessary

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

Not necessary

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：

Blinding：

None

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）：

IPD will not be shared.

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

IPD will not be shared.国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

IPD will not be shared.

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

IPD will not be shared. EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-11-25 08:37:04
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统