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A pilot mixed methods study of a camouflaged WeChat miniprogram-based intervention for women victims of intimate partner violence
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注册号：

Registration number：

 ChiCTR2500111363 

最近更新日期：

Date of Last Refreshed on：

 2025-10-30 10:37:07 

注册时间：

Date of Registration：

 2025-10-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A pilot mixed methods study of a camouflaged WeChat miniprogram-based intervention for women victims of intimate partner violence

Public title：

A pilot mixed methods study of a camouflaged WeChat miniprogram-based intervention for women victims of intimate partner violence

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A pilot mixed methods study of a camouflaged WeChat miniprogram-based intervention for women victims of intimate partner violence

Scientific title：

A pilot mixed methods study of a camouflaged WeChat miniprogram-based intervention for women victims of intimate partner violence

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：

Quanlei Li 

研究负责人：

Quanlei Li 

Applicant：

Quanlei Li 

Study leader：

Quanlei Li 

申请注册联系人电话：

Applicant telephone：

 +852 3917 7577

研究负责人电话：

Study leader's
telephone：

+852 3917 7577

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：

 qli1@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 qli1@hku.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：

3 Sassoon Road, Pokfulam, Hong Kong

研究负责人通讯地址：

3 Sassoon Road, Pokfulam, Hong Kong

Applicant address：

3 Sassoon Road, Pokfulam, Hong Kong

Study leader's address：

3 Sassoon Road, Pokfulam, 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 University of Hong Kong

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

The University of Hong Kong

Affiliation of the Leader：

The 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：

 UW24-806

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：

nstitutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

Name of the ethic committee：

nstitutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-22 00:00:00

伦理委员会联系人：

Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

Contact Name of the ethic committee：

Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

伦理委员会联系地址：

Room 901, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Contact Address of the ethic committee：

Room 901, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 4086

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkwirb@ha.org.hk

研究实施负责（组长）单位：

School of Nursing, the University of Hong Kong

Primary sponsor：

School of Nursing, the University of Hong Kong

研究实施负责（组长）单位地址：

3 Sassoon Road, Pokfulam, Hong Kong

Primary sponsor's address：

3 Sassoon Road, Pokfulam, Hong Kong

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)：

Li Ka Shing Faculty of Medicine, the University of Hong Kong

具体地址：

3 Sassoon Road, Pokfulam, Hong Kong

Institution
hospital：

Li Ka Shing Faculty of Medicine, the University of Hong Kong

Address：

3 Sassoon Road, Pokfulam, Hong Kong

经费或物资来源：

Health and Medical Research Fund

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

Intimate Partner Violence  

Target disease：

Intimate Partner Violence

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：

随机平行对照 

Study design：

Parallel 

研究目的：

(1) To develop the WeChat mini-program for empowering and supporting women victims, which is disguised as a commonly seen healthy lifestyle tool; (2) To examine the feasibility and acceptability of the WOMEN Health programme; (3) To explore the preliminary efficacy of the WOMEN Health programme on women victims’ depressive symptoms, quality of life, IPV, as well as body mass index (BMI) and healthy behaviors.  

Objectives of Study：

(1) To develop the WeChat mini-program for empowering and supporting women victims, which is disguised as a commonly seen healthy lifestyle tool; (2) To examine the feasibility and acceptability of the WOMEN Health programme; (3) To explore the preliminary efficacy of the WOMEN Health programme on women victims’ depressive symptoms, quality of life, IPV, as well as body mass index (BMI) and healthy behaviors;

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Unwilling to provide informed consent; 2. Severe chronic diseases (e.g., cancer, heart failure, kidney failure, chronic obstructive pulmonary disease, and HIV/AIDS); 3. Currently experience severe IPV (identified using the revised 11-item Danger Assessment).

Exclusion criteria：

1. Unwilling to provide informed consent; 2. Severe chronic diseases (e.g., cancer, heart failure, kidney failure, chronic obstructive pulmonary disease, and HIV/AIDS); 3. Currently experience severe IPV (identified using the revised 11-item Danger Assessment).

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2027-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-01 00:00:00 至 To 2026-01-01 00:00:00

干预措施：

Interventions：

组别：

WOMEN Health group

样本量：

 43

Group：

WOMEN Health group

Sample size：

干预措施：

Empowerment (IPV information, ie, 30-min one-to-one interview, WeChat mini-program), Telephone social support (ie, weekly calls), Healthy lifestyle intervention (ie, healthy lifestyle information and discussion)

干预措施代码：

Intervention：

Empowerment (IPV information, ie, 30-min one-to-one interview, WeChat mini-program), Telephone social support (ie, weekly calls), Healthy lifestyle intervention (ie, healthy lifestyle information and discussion)

Intervention code：

组别：

Wait-list control group

样本量：

 43

Group：

Wait-list control group

Sample size：

干预措施：

Healthy lifestyle intervention (ie, discussion and weekly calls for body weight)

干预措施代码：

Intervention：

Healthy lifestyle intervention (ie, discussion and weekly calls for body weight)

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)：

 Li Ka Shing Faculty of Medicine, the University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Li Ka Shing Faculty of Medicine, the University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

The feasibility and acceptability of the WOMEN Health programme

指标类型：

主要指标

Outcome：

The feasibility and acceptability of the WOMEN Health programme

Type：

Primary indicator

测量时间点：

Baseline and post-intervention

测量方法：

A 12-item evaluation questionnaire has been developed to assess the acceptability, satisfaction, and usefulness of the intervention.

Measure time point of outcome：

Baseline and post-intervention

Measure method：

A 12-item evaluation questionnaire has been developed to assess the acceptability, satisfaction, and usefulness of the intervention.

指标中文名：

Changes in depressive symptoms

指标类型：

次要指标

Outcome：

Changes in depressive symptoms

Type：

Secondary indicator

测量时间点：

Baseline and post-intervention

测量方法：

Chinese version of the Beck Depression Inventory-II (BDI-II) in the past two weeks

Measure time point of outcome：

Baseline and post-intervention

Measure method：

Chinese version of the Beck Depression Inventory-II (BDI-II) in the past two weeks

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

Baseline and post-intervention

测量方法：

Chinese version of the 12-item Short Form version 2 Health Survey (SF-12v2) between baseline and post-intervention

Measure time point of outcome：

Baseline and post-intervention

Measure method：

Chinese version of the 12-item Short Form version 2 Health Survey (SF-12v2) between baseline and post-intervention

指标中文名：

Intimate partner violence (IPV)

指标类型：

次要指标

Outcome：

Intimate partner violence (IPV)

Type：

Secondary indicator

测量时间点：

Baseline and post-intervention

测量方法：

Chinese version of the Revised Conflict Tactics Scales (CTS2)

Measure time point of outcome：

Baseline and post-intervention

Measure method：

Chinese version of the Revised Conflict Tactics Scales (CTS2)

指标中文名：

Body-Mass Index (BMI)

指标类型：

次要指标

Outcome：

Body-Mass Index (BMI)

Type：

Secondary indicator

测量时间点：

Baseline and post-intervention

测量方法：

BMI based on WHO recommendations for Asian populations between baseline and post-intervention between baseline and post-intervention

Measure time point of outcome：

Baseline and post-intervention

Measure method：

BMI based on WHO recommendations for Asian populations between baseline and post-intervention between baseline and post-intervention

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Participants will be randomized in a 1:1 ratio to the intervention or control group by the researcher using opaque sealed envelopes, which were prepared by a blinded research member using a computer-generated randomization list

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

Participants will be randomized in a 1:1 ratio to the intervention or control group by the researcher using opaque sealed envelopes, which were prepared by a blinded research member using a computer-generated randomization list.

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：

Participants and the researcher will be nonblinded, whereas all other research members will be blinded to allocation and intervention.

Blinding：

Participants and the researcher will be nonblinded, whereas all other research members will be blinded to allocation and intervention.

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）：

In order to protect the privacy of subjects, the original data will not be shared, and the investigator can be contacted to obtain it if necessary.

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

In order to protect the privacy of subjects, the original data will not be shared, and the investigator can be contacted to obtain it if necessary.

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：

The data were collected by the researchers through paper documents and recording, and were uniformly stored by the research assistant.

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

The data were collected by the researchers through paper documents and recording, and were uniformly stored by the research assistant.

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：

  2025-10-30 10:36:53
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