ChiCTR2100051289 版本V1.0 版本创建时间2021/09/19 23:42:54 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：

 ChiCTR2100051289 

最近更新日期：

Date of Last Refreshed on：

 2021-09-18 10:15:28 

注册时间：

Date of Registration：

 2021-09-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

‘Cooking with Love’: Social integration programme for new arrivals in Hong Kong

Public title：

‘Cooking with Love’: Social integration programme for new arrivals in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

School-based Mindfulness Intervention with Migrant Children in China

Scientific title：

Effectiveness of a mindful cooking intervention for new arrivals in Hong Kong

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：

卢霜 

研究负责人：

卢霜 

Applicant：

Shuang Lu 

Study leader：

Shuang Lu 

申请注册联系人电话：

Applicant telephone：

 +852 39172080

研究负责人电话：

Study leader's
telephone：

+852 39172080

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：

 shuanglu@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 shuanglu@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：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

研究负责人通讯地址：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

Applicant address：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

Study leader's address：

Jockey Club Tower, 5/F, Pokfulam Rd, 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：

香港大學社會科學學院

Applicant's institution：

The University of Hong Kong, Department of Social Work and Social Administration

研究负责人所在单位：

香港大學社會科學學院

Affiliation of the Leader：

The University of Hong Kong, Department of Social Work and Social Administration

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：

 EA210396

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：

香港大學人類研究倫理委員會

Name of the ethic committee：

The University of Hong Kong Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-09-08 00:00:00

伦理委员会联系人：

Becky Wong

Contact Name of the ethic committee：

Becky Wong

伦理委员会联系地址：

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

Contact Address of the ethic committee：

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 28598039

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：

New Home Association

Primary sponsor：

New Home Association

研究实施负责（组长）单位地址：

7/F, Sin Hua Bank Building, 122 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong

Primary sponsor's address：

7/F, Sin Hua Bank Building, 122 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

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)：

香港大學

具体地址：

Jockey Club Tower, 5/F, Pokfulam Rd

Institution
hospital：

The University of Hong Kong

Address：

Jockey Club Tower, 5/F, Pokfulam Rd

经费或物资来源：

New Home Association project consultancy service

Source(s) of funding：

New Home Association project consultancy service

研究疾病：

Psychosocial well-being  

Target disease：

Psychosocial well-being

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

(1) To examine the effectiveness of the community-based mindful cooking intervention on emotional well-being, mindfulness, health-related quality of life, and self-esteem among new migrants and local residents. (2) To improve the intergroup contact between new migrants and local residents in the community, increasing their interaction, enhancing mutual understanding, improving their attitude and intended behavior toward each other.  

Objectives of Study：

(1) To examine the effectiveness of the community-based mindful cooking intervention on emotional well-being, mindfulness, health-related quality of life, and self-esteem among new migrants and local residents. (2) To improve the intergroup contact between new migrants and local residents in the community, increasing their interaction, enhancing mutual understanding, improving their attitude and intended behavior toward each other.

药物成份或治疗方案详述：

The 4-week intervention integrates mindfulness practices (e.g., sitting meditation, mindful eating, body scan) with cooking elements. Didactic lectures, cooking activities, mindful practices, and group sharing will be used in each session. Session 1: Self-introduction, introduce mindfulness concepts and basic techniques during the process of cooking. Session 2: Body scan and standing yoga and cooking, notice our feelings when it exceeds our body limits (e.g., too spicy). Session 3: Sitting meditation, focus on present moment and be aware of patterns of reactions to challenges when baking a lemon tart. Session 4: bake a chiffon cake, concluding meditation. 

Description for medicine or protocol of treatment in detail：

The 4-week intervention integrates mindfulness practices (e.g., sitting meditation, mindful eating, body scan) with cooking elements. Didactic lectures, cooking activities, mindful practices, and group sharing will be used in each session. Session 1: Self-introduction, introduce mindfulness concepts and basic techniques during the process of cooking. Session 2: Body scan and standing yoga and cooking, notice our feelings when it exceeds our body limits (e.g., too spicy). Session 3: Sitting meditation, focus on present moment and be aware of patterns of reactions to challenges when baking a lemon tart. Session 4: bake a chiffon cake, concluding meditation. 

纳入标准：

(1) adults aged or above 18 years (including new migrants and local residents) in Hong Kong;
(2) New migrants should be newly arrived immigrants from Mainland having resided in Hong Kong for less than 7 years, while local residents should be people who were born in Hong Kong or having been living in Hong Kong for 12 years or longer;
(3) The 21-item Depression, Anxiety and Stress Scale (DASS-21) will be used in screening to identify potential participants. New migrants and local residents who are identified as having elevated risk of depression, anxiety, and/or stress will be invited to join the study.

Inclusion criteria

(1) adults aged or above 18 years (including new migrants and local residents) in Hong Kong;
(2) New migrants should be newly arrived immigrants from Mainland having resided in Hong Kong for less than 7 years, while local residents should be people who were born in Hong Kong or having been living in Hong Kong for 12 years or longer;
(3) The 21-item Depression, Anxiety and Stress Scale (DASS-21) will be used in screening to identify potential participants. New migrants and local residents who are identified as having elevated risk of depression, anxiety, and/or stress will be invited to join the study.

排除标准：

Adults who are reported to have serious physical (e.g., insufficient visual abilities to complete intervention) and mental conditions (e.g., psychosis) will be excluded from this study.

Exclusion criteria：

Adults who are reported to have serious physical (e.g., insufficient visual abilities to complete intervention) and mental conditions (e.g., psychosis) will be excluded from this study.

研究实施时间：

Study execute time：

从 From 2021-09-15 00:00:00至 To 2024-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-19 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

Treatment group

样本量：

 70

Group：

Treatment group

Sample size：

干预措施：

Mindful cooking

干预措施代码：

Intervention：

Mindful cooking

Intervention code：

组别：

Control group

样本量：

 70

Group：

Control group

Sample size：

干预措施：

Waitlist control

干预措施代码：

Intervention：

Waitlist control

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)：

 New Home Association service centers 

单位级别：

  

Institution
hospital：

New Home Association service centers

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Depression, anxiety and/or stress

指标类型：

主要指标

Outcome：

Depression, anxiety and/or stress

Type：

Primary indicator

测量时间点：

Immediate post-intervention

测量方法：

DASS-21

Measure time point of outcome：

Immediate post-intervention

Measure method：

DASS-21

指标中文名：

Intergroup interaction

指标类型：

次要指标

Outcome：

Intergroup interaction

Type：

Secondary indicator

测量时间点：

Immediate post-intervention

测量方法：

Measure time point of outcome：

Immediate post-intervention

Measure method：

指标中文名：

Mindfulness

指标类型：

附加指标

Outcome：

Mindfulness

Type：

Additional indicator

测量时间点：

Immediate post-intervention

测量方法：

Measure time point of outcome：

Immediate post-intervention

Measure method：

指标中文名：

Cooking attitude and behavior

指标类型：

附加指标

Outcome：

Cooking attitude and behavior

Type：

Additional indicator

测量时间点：

Immediate post-intervention

测量方法：

Measure time point of outcome：

Immediate post-intervention

Measure method：

指标中文名：

Self-esteem

指标类型：

附加指标

Outcome：

Self-esteem

Type：

Additional indicator

测量时间点：

Immediate post-intervention

测量方法：

Measure time point of outcome：

Immediate post-intervention

Measure method：

指标中文名：

Health status

指标类型：

附加指标

Outcome：

Health status

Type：

Additional indicator

测量时间点：

Immediate post-intervention

测量方法：

Measure time point of outcome：

Immediate post-intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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 100 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）：

A quasi experiment with waitlist control design will be used. During the 3-year period of this project, we will conduct mindful cooking intervention on a rolling basis. Participants will be recruited and assigned into a 4-week mindful cooking intervention group and a wait-list control group based on their s

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

A quasi experiment with waitlist control design will be used. During the 3-year period of this project, we will conduct mindful cooking intervention on a rolling basis. Participants will be recruited and assigned into a 4-week mindful cooking intervention group and a wait-list control group based on their s

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：

Outcome assessors (research assistants and/or social workers) will be blinded from treatment allocation

Blinding：

Outcome assessors (research assistants and/or social workers) will be blinded from treatment allocation

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）：

https://datahub.hku.hk/

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

https://datahub.hku.hk/

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：

Indirect personal identifiers (a numeric code assigned to each participant) will be used to link participants to their responses. The anonymized data will be kept for 5 years after publication of research results.

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

Indirect personal identifiers (a numeric code assigned to each participant) will be used to link participants to their responses. The anonymized data will be kept for 5 years after publication of research results.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-09-18 10:15:29