ChiCTR2100052752 版本V1.0 版本创建时间2022/08/15 23:02:02 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：

 ChiCTR2100052752 

最近更新日期：

Date of Last Refreshed on：

 2021-11-05 00:31:06 

注册时间：

Date of Registration：

 2021-11-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised controlled trial

Public title：

The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised controlled trial

Scientific title：

The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised 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：

WAN Ting 

研究负责人：

WAN Ting 

Applicant：

WAN Ting 

Study leader：

WAN Ting 

申请注册联系人电话：

Applicant telephone：

 +852 98215508

研究负责人电话：

Study leader's
telephone：

+852 98215508

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：

 wantinglindalinda@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 wantinglindalinda@gmail.com

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：

Ward J3, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR

研究负责人通讯地址：

Ward J3, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR

Applicant address：

Ward J3, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR

Study leader's address：

Ward J3, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong SAR

申请注册联系人邮政编码：

Applicant postcode：

 852

研究负责人邮政编码：

Study leader's postcode：

 852

申请人所在单位：

香港東區尤德夫人那打素醫院

Applicant's institution：

Department of Psychiatry

研究负责人所在单位：

香港東區尤德夫人那打素醫院

Affiliation of the Leader：

Pamela Youde Nethersole Eastern Hospital

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：

 2021.411

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

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：

 2021-09-02 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：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

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：

N/A

Primary sponsor：

NA

研究实施负责（组长）单位地址：

NA

Primary sponsor's address：

NA

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

NA

研究疾病：

精神分裂症  

Target disease：

Schizophrenia

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：

To examine the acceptability and feasibility of the information-behavioural-motivation (IMB) based multimodal intervention (WALK-Beat-S program) and to evaluate its potential effects on body weight (BW) (primary outcome), other anthropometric parameters, including waist circumferences (WC), systolic blood pressure (SBP) and diastolic blood pressure (DBP), psychotic symptoms, physical activity levels and dietary behaviour, of adults with schizophrenia who are overweight or obese, compared with standard care at immediate post-intervention and one-month post-intervention.  

Objectives of Study：

To examine the acceptability and feasibility of the information-behavioural-motivation (IMB) based multimodal intervention (WALK-Beat-S program) and to evaluate its potential effects on body weight (BW) (primary outcome), other anthropometric parameters, including waist circumferences (WC), systolic blood pressure (SBP) and diastolic blood pressure (DBP), psychotic symptoms, physical activity levels and dietary behaviour, of adults with schizophrenia who are overweight or obese, compared with standard care at immediate post-intervention and one-month post-intervention.

药物成份或治疗方案详述：

A 12-week (eight-session) WALK-Beat-S program which includes 1) four weekly 60-minute face-to-face group physical activity and dietary education with practical session (the first and second sessions will be delivered face-to-face, and the third and fourth sessions will be delivered in an real-time online group format via Zoom/WeChat or face-to-face approach (depends on pandemic situation), 2) followed by three 30-minute bi-weekly individual telephone contacts at the sixth, eighth and tenth week, 3) then a final 60-minute face-to-face group celebration session at twelfth week. The participants are encouraged to perform daily moderate intensity walking exercise and maintain healthy eating behaviour throughout the intervention period. Continued social support from peers via mobile application (WeChat) will be provided. 

Description for medicine or protocol of treatment in detail：

A 12-week (eight-session) WALK-Beat-S program which includes 1) four weekly 60-minute face-to-face group physical activity and dietary education with practical session (the first and second sessions will be delivered face-to-face, and the third and fourth sessions will be delivered in an real-time online group format via Zoom/WeChat or face-to-face approach (depends on pandemic situation), 2) followed by three 30-minute bi-weekly individual telephone contacts at the sixth, eighth and tenth week, 3) then a final 60-minute face-to-face group celebration session at twelfth week. The participants are encouraged to perform daily moderate intensity walking exercise and maintain healthy eating behaviour throughout the intervention period. Continued social support from peers via mobile application (WeChat) will be provided. 

纳入标准：

1. Chinese adults and aged from 18 to 64 years;
2. BMI>=23 kg/m2;
3. Have been diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) or 5th edition (DSM-V), or the International Statistical Classification of Diseases and Related Health Problem, 10th Revision (ICD-10);
4. Able to read and write in Chinese, and able to understand Cantonese;
5. Mentally fit to provide consent as confirmed by attending psychiatrist;
6. Able to use apps installed on a smartphone (e.g., WeChat, Pedometer app).

Inclusion criteria

1. Chinese adults and aged from 18 to 64 years;
2. BMI>=23 kg/m2;
3. Have been diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) or 5th edition (DSM-V), or the International Statistical Classification of Diseases and Related Health Problem, 10th Revision (ICD-10);
4. Able to read and write in Chinese, and able to understand Cantonese;
5. Mentally fit to provide consent as confirmed by attending psychiatrist;
6. Able to use apps installed on a smartphone (e.g., WeChat, Pedometer app).

排除标准：

1. Currently receiving enrolled in diet control and/or regular physical activity program;
2. Any physical impairment that barrier to participating in an exercise program;
3. Prior bariatric surgery;
4. Currently receiving cancer treatment;
5. Having the problem of harmful or dependent use of the substance;
6. Diagnosis of an eating disorder, including anorexia nervosa, bulimia nervosa, mental retardation or organic brain disorders;
7. Breastfeeding or being pregnant at recruitment.

Exclusion criteria：

1. Currently receiving enrolled in diet control and/or regular physical activity program;
2. Any physical impairment that barrier to participating in an exercise program;
3. Prior bariatric surgery;
4. Currently receiving cancer treatment;
5. Having the problem of harmful or dependent use of the substance;
6. Diagnosis of an eating disorder, including anorexia nervosa, bulimia nervosa, mental retardation or organic brain disorders;
7. Breastfeeding or being pregnant at recruitment.

研究实施时间：

Study execute time：

从 From 2021-09-01 00:00:00至 To 2022-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-11-15 00:00:00 至 To 2022-03-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 38

Group：

1

Sample size：

干预措施：

WALK-Beat-S Program

干预措施代码：

Intervention：

WALK-Beat-S Program

Intervention code：

组别：

2

样本量：

 38

Group：

2

Sample size：

干预措施：

Standard Care

干预措施代码：

Intervention：

Standard Care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 東區尤德夫人那打素醫院 

单位级别：

 三甲医院 

Institution
hospital：

Pamela Youde Nethersole Eastern Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Body Weight

指标类型：

主要指标

Outcome：

Body Weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Waist Circumferences

指标类型：

次要指标

Outcome：

Waist Circumferences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

Measure method：

指标中文名：

Psychotic symptoms

指标类型：

次要指标

Outcome：

Psychotic symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Dietary behaviour

指标类型：

次要指标

Outcome：

Dietary behaviour

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical activity level

指标类型：

次要指标

Outcome：

Physical activity level

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：

No

组织：

Sample Name：

NA

Tissue：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 64 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）：

Participants will be randomly allocated into an intervention group (WALK-Beat-S program) or a control group (standard care) by using block randomisation on a 1:1 ratio, with a block size of six and eight. A clerical staff independent from the study will generate random codes by a random allocation software&

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

Participants will be randomly allocated into an intervention group (WALK-Beat-S program) or a control group (standard care) by using block randomisation on a 1:1 ratio, with a block size of six and eight. A clerical staff independent from the study will generate random codes by a random allocation software&

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：

Not stated

Blinding：

Assessor-blinded

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）：

No

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：

No

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：

有/Yes

注册人：

Name of Registration：

  2021-11-05 00:31:06