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Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study
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注册号：

Registration number：

 ChiCTR-TRC-12002624 

最近更新日期：

Date of Last Refreshed on：

 2015-04-30 19:23:31 

注册时间：

Date of Registration：

 2012-10-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

Public title：

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

Scientific title：

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

研究课题代号(代码)：

Study subject ID：

 10110911

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：

CUHK_CCT00342

申请注册联系人：

Hung-kwan So 

研究负责人：

Edmund Anthony Nelson 

Applicant：

Hung-kwan So 

Study leader：

Edmund Anthony Nelson 

申请注册联系人电话：

Applicant telephone：

 +852 26322829

研究负责人电话：

Study leader's
telephone：

+852 26322861

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：

 sohk@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 tony-nelson@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：

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

研究负责人通讯地址：

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

Applicant address：

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

Study leader's address：

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

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：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 NA

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Chinese University of Hong Kong

Name of the ethic committee：

Chinese University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2012-01-10 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

Food and Health Bureau Hong Kong

Primary sponsor：

Food and Health Bureau Hong Kong

研究实施负责（组长）单位地址：

Food and Health Bureau Hong Kong

Primary sponsor's address：

Food and Health Bureau Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Health and Health Services Research Fund

Source(s) of funding：

Health and Health Services Research Fund

研究疾病：

obesity  

Target disease：

obesity

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：

Internet-based obesity prevention programs with cell phone follow up and family participation;Duration of intervention:12 week internet curriculum and cell phone follow up over 24 weeks.;Description / name of comparative treatments:For this pilot study there will be one control group and two different intervention groups. The control group will also receive usual care which consists of visits to the obesity clinic staffed by a paediatrician every three months while the first intervention group will receive visits to the obesity clinic every 3 months plus 12 week internet curriculum and cell phone follow up over 24 weeks. The second intervention group will receive visits to the obesity clinic every three months and three meetings with a nutritionist over three months.  

Objectives of Study：

Internet-based obesity prevention programs with cell phone follow up and family participation;Duration of intervention:12 week internet curriculum and cell phone follow up over 24 weeks.;Description / name of comparative treatments:For this pilot study there will be one control group and two different intervention groups. The control group will also receive usual care which consists of visits to the obesity clinic staffed by a paediatrician every three months while the first intervention group will receive visits to the obesity clinic every 3 months plus 12 week internet curriculum and cell phone follow up over 24 weeks. The second intervention group will receive visits to the obesity clinic every three months and three meetings with a nutritionist over three months.

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：

BMI below 95th percentile of local reference, concurrent participation in any clinical trial, dietary intervention or weight loss program, concomitant intake of a weight reducing agent, any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study, unwillingness to attend regular follow up appointments as part of the intervention programme.

Exclusion criteria：

BMI below 95th percentile of local reference, concurrent participation in any clinical trial, dietary intervention or weight loss program, concomitant intake of a weight reducing agent, any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study, unwillingness to attend regular follow up appointments as part of the intervention programme.

研究实施时间：

Study execute time：

从 From 2013-02-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2013-02-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

样本量：

 4

Group：

Three groups

Sample size：

干预措施：

干预措施代码：

Intervention：

Internet-based obesity prevention programs 12 weeks and cell phone follow up and family participation over 24 weeks versus usual care which consists of visits to the obesity clinic staffed by a paediatrician every three months while the first intervention group will receive visits to the obesity clinic every 3 months plus 12 week internet curriculum and cell phone follow up over 24 weeks. The second intervention group will receive visits to the obesity clinic every three months and three meeting

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)：

 Chinese University of Hong Kong 

单位级别：

 Chinese University of Hong Kong 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

recruitment and retention rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

internet log-in rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

compliance and satisfaction with counselling, curr

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: physical activity level

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: dietary intake

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: dietary intake

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: stress level

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: knowledge related to nutrition/

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: weight and blood pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Secondary outcome: effect of the program on these

Type：

Primary 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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 14 岁 years
最大 Max age 18 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）：

Radom

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

Radom

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：

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

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）：

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

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：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2012-10-26 00:00:00
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