ChiCTR2300071334 版本V1.1 版本创建时间2023/06/09 11:42:15 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300071334 

最近更新日期：

Date of Last Refreshed on：

 2023-05-11 15:40:08 

注册时间：

Date of Registration：

 2023-05-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effectiveness of combined social media and family support on physical activity intervention on Chinese mid-to-old age retired adults in Hong Kong: a 10-week randomized controlled trial

Public title：

Effectiveness of combined social media and family support on physical activity intervention on Chinese retired adults in Hong Kong: a 10-week randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of combined social media and family support on physical activity intervention on Chinese retired adults in Hong Kong: a 10-week randomized controlled trial

Scientific title：

Effectiveness of combined social media and family support on physical activity intervention on Chinese retired adults in Hong Kong: a 10-week randomized controlled trial

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：

HUANG Ying 

研究负责人：

HUANG Ying 

Applicant：

HUANG Ying 

Study leader：

HUANG Ying 

申请注册联系人电话：

Applicant telephone：

 +852 5126 2406

研究负责人电话：

Study leader's
telephone：

+852 5126 2406

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：

 yinghuang@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yinghuang@link.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：

Room108, University Sport Centre, The Chinese University of Hong Kong, Hong Kong

研究负责人通讯地址：

Room108, University Sport Centre, The Chinese University of Hong Kong, Hong Kong

Applicant address：

The Chinese University of Hong Kong

Study leader's address：

The Chinese University of 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

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：

 2022-356

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 CREC

Name of the ethic committee：

Joint CUHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-08-12 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：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong, Hong Kong, China

Primary sponsor's address：

The Chinese University of Hong Kong, Hong Kong, 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)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

The Chinese University of Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong

经费或物资来源：

The Chinese University of Hong Kong

Source(s) of funding：

The Chinese University of Hong Kong

研究疾病：

Physical inactivity  

Target disease：

Physical inactivity

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aim of the current trial is to evaluate the effectiveness of a combined social media and social support intervention regarding changes in the objective measurement of physical activity, psychological needs satisfaction, life satisfaction, and subjective well-being among Chinese retired adults in Hong Kong.  

Objectives of Study：

The aim of the current trial is to evaluate the effectiveness of a combined social media and social support intervention regarding changes in the objective measurement of physical activity, psychological needs satisfaction, life satisfaction, and subjective well-being among Chinese retired adults in Hong Kong.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Participants who were aged 50 years and older; retired or without jobs (both full-time and part-time); fluent in Chinese; physically mobile (have no contraindications towards physical activity, assessed by the Physical Activity Readiness Questionnaire (Thomas et al., 1992)); healthy or having common chronic diseases but ambulatory; having Internet access and a device capable of accessing online videos; and able to provide written consent form were invited to the study.

Inclusion criteria

Participants who were aged 50 years and older; retired or without jobs (both full-time and part-time); fluent in Chinese; physically mobile (have no contraindications towards physical activity, assessed by the Physical Activity Readiness Questionnaire (Thomas et al., 1992)); healthy or having common chronic diseases but ambulatory; having Internet access and a device capable of accessing online videos; and able to provide written consent form were invited to the study.

排除标准：

Individuals who have jobs, aged below 50 years; have contraindications towards physical activity; do not have access to the internet, unable to provide a written consent form were excluded from the current study.

Exclusion criteria：

Individuals who have jobs, aged below 50 years; have contraindications towards physical activity; do not have access to the internet, unable to provide a written consent form were excluded from the current study.

研究实施时间：

Study execute time：

从 From 2022-07-01 00:00:00至 To 2023-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-08-26 00:00:00 至 To 2023-01-31 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 72

Group：

Experimental group

Sample size：

干预措施：

Physical activity education class

干预措施代码：

Intervention：

Physical activity education class

Intervention code：

组别：

Control group

样本量：

 73

Group：

Control group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

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 Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Moderate-to-vigorous physical activity

指标类型：

主要指标

Outcome：

Moderate-to-vigorous physical activity

Type：

Primary indicator

测量时间点：

测量方法：

ActiGraph wGT3X-BT accelerometers worn at the waist during waking hours

Measure time point of outcome：

Measure method：

ActiGraph wGT3X-BT accelerometers worn at the waist during waking hours

指标中文名：

Adherence to physical activity guidelines

指标类型：

次要指标

Outcome：

Adherence to physical activity guidelines

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Life satisfaction

指标类型：

次要指标

Outcome：

Life satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Loneliness level

指标类型：

次要指标

Outcome：

Loneliness level

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

SDT-related basic psychological needs satisfaction and motivation towards physical activity

指标类型：

次要指标

Outcome：

SDT-related basic psychological needs satisfaction and motivation towards physical activity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Sedentary time

指标类型：

次要指标

Outcome：

Sedentary time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 75 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）：

The authors conducted randomisation using Microsoft Office Excel software (using the random numbers generated by the software) to determine who would be allocated to the intervention group or the wait-list control group at a 1:1 ratio.

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

The authors conducted randomization using the Microsoft Office Excel software, (using the random numbers generated by the software) to determine who would be allocated to the experimental group or the wait-list control group at a 1:1 ratio.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Participants were not told the group allocation until they had completed the baseline measurements.

Blinding：

Participants were not told the group allocation until they had completed the baseline measurements.

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）：

ResMan

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

ResMan

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：

Any data collected in the study will be strictly confidential and will be used for research purposes only. All private identifiable information (i.e. name) will be replaced by number when conducting data analysis and in all publications. Data will be stored securely in PI’s password-protected portable hard drive and computer for ten years.

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

Any data collected in the study will be strictly confidential and will be used for research purposes only. All private identifiable information (i.e. name) will be replaced by number when conducting data analysis and in all publications. Data will be stored securely in PI’s password-protected portable hard drive and computer for ten years.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-11 15:40:02