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对有妊娠糖尿病史的农村妇女实施生活方式强化训练
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注册号:

Registration number:

ChiCTR1800015023 

最近更新日期:

Date of Last Refreshed on:

2018-03-01 

注册时间:

Date of Registration:

2018-03-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

对有妊娠糖尿病史的农村妇女实施生活方式强化训练 

Public title:

Diabetes prevention program for rural women with prior gestational diabetes mellitus: A multi-site randomized clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

对有妊娠糖尿病史的农村妇女实施生活方式强化训练 

Scientific title:

Diabetes prevention program for rural women with prior gestational diabetes mellitus: A multi-site randomized clinical 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:

郭佳 

研究负责人:

郭佳 

Applicant:

Jia Guo 

Study leader:

Jia Guo 

申请注册联系人电话:

Applicant telephone:

+86 13875947418 

研究负责人电话:

Study leader's telephone:

+86 13875947418 

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:

guojia@163.com 

研究负责人电子邮件:

Study leader's E-mail:

guojia@163.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:

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅护理学院 

研究负责人通讯地址:

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅护理学院 

Applicant address:

172 Tongzipo Road, Changsha, Hu'nan, China 

Study leader's address:

172 Tongzipo Road, Changsha, Hu'nan, China 

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:

中南大学湘雅护理学院 

Applicant's institution:

Xiangya School of Nursing, Central South University 

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:

2016034 

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:

中南大学湘雅护理学院护理与行为医学研究伦理审查委员会 

Name of the ethic committee:

Nursing and Behavioral medicine Institutional Review Board of Xiangya Nursing School of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-11 

伦理委员会联系人:

杨敏 

Contact Name of the ethic committee:

Min Yang 

伦理委员会联系地址:

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅护理学院 

Contact Address of the ethic committee:

Xiangya School of Nursing, Central South University, 172 Tongzipo Road, Changsha, Hu'nan, China 

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:

470110692@qq.com 

研究实施负责(组长)单位:

中南大学 

Primary sponsor:

Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市岳麓区麓山南路932号 

Primary sponsor's address:

932 Lushan South Road, Changsha, Hu'nan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

美国中华基金会 

Source(s) of funding:

China Medical Board 

研究疾病:

2型糖尿病 

Target disease:

Type 2 diabetes mellitus 

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 

研究目的:

主要研究目的: 与对照组相比,在基线评估后的3,6和18个月,产后强化生活方式项目(ILSM)对生理结局(T2DM的发展,胰岛素抵抗和体重相关变量),健康行为(饮食摄入和体育锻炼),心理社会因素(自我效能,感知压力和社会支持)以及心理社会结果(生活质量)的影响。 次要研究目的: 1)探索影响生理结局和社会心理结局(中介影响)变化的潜在先决条件因素的变化。 2)确定影响ILSM项目在改变生理结局和社会心理结局(调节影响)方面的有效程度的因素。 3)评估ILSM项目的成本和潜在的在成本效益。 

Objectives of Study:

Primary: To examine the effect of a postpartum intensive lifestyle modification (ILSM) program on physiological health outcomes (T2DM development, insulin resistance, and weight-related variables), health behaviors (dietary intake and physical activity), psychosocial factors (self-efficacy, perceived stress, and social support), and psychosocial outcomes (quality of life) compared to usual care at 3, 6, and 18 months post baseline assessment. Secondary: 1) To explore changes in factors which are potential prerequisites for change in physiological health outcomes and psychosocial outcomes (mediating influences). 2) To identify factors that influence the degree to which the ILSM program is effective in change of physiological health outcomes and psychosocial outcomes (moderating influences). 3) To assess the cost and potential cost effectiveness of the ILSM program.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

有妊娠糖尿病的妇女;18 岁及以上;有农村户口;在研究开始时已是产后6周;会在样本县居住3年以上;会在样本县妇幼保健院接受妇幼保健服务3年以上;有家属、朋友、邻居的联系电话;有汉字读写能力。  

Inclusion criteria

Women with a history of GDM; 18 years or older; at least six weeks post-partum at the beginning of the study; intend to live in the research counties for at least 3 years; intend to seek primary maternal and child health care in the research sites for at least 3 years; have telephone-access either from family members, friends, or neighbors; be able to speak Chinese.  

排除标准:

在未来三年中计划怀孕者;正在怀孕者;在怀孕前或产后诊断糖尿病者;服用影响糖代谢药物者;多胞胎母亲(3个及以上);身体残疾或认知障碍者;药物滥用者;严重精神疾病患者。  

Exclusion criteria:

Planning to become pregnant within the next three years; Currently pregnant; Diabetes diagnosed before pregnancy or after delivery; Medications that influence glucose metabolism; Multiple pregnancies (three or more); Physical or cognitive disability; Current addictive drug abuse; Severe psychiatric disorders. 

研究实施时间:

Study execute time:

From2017-01-01To 2019-12-30 

征募观察对象时间:

Recruiting time:

From2017-07-01To 2018-06-30 

干预措施:

Interventions:

组别:

干预组

样本量:

160

Group:

intervention group

Sample size:

干预措施:

产后生活方式强化训练

干预措施代码:

Intervention:

Intensive Lifestyle Modification

Intervention code:

组别:

对照组

样本量:

160

Group:

Control

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口服葡萄糖耐量试验

指标类型:

主要指标 

Outcome:

OGTT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体质量指数

指标类型:

主要指标 

Outcome:

Body Mass Index

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:

标本中文名:

血液

组织:

Sample Name:

blood

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

以张家界永定区和株洲市攸县为研究地点。两县农村人口分别占50%以上,两县出生率相近,乡镇数量相似(20比17)。每个县大约一半乡镇将被选中并随机分配到ILSM条件,其余乡镇分配至对照组。Wiley博士(生物统计学家)将会应用一个网上随机抽样工具来抽取符合要求的研究对象(http://stattrek.com/statistics/random-number-generator.aspx)。每个乡镇符合要求的研究对象将被邀请加入研究。

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

Yongding county in Zhangjiajie and Youxian county in Zhuzhou city will be chosen as the sites for this study. The rural population of the two counties accounted over 50% respectively, the birth rate of the two counties as aforementioned, and the number of the towns are similar (20 vs 17). In eit

盲法:

鉴于在干预的特殊性,我们不可能给研究对象和研究团队安排的专家们戴面具或口罩。然而数据收集者与研究对象双盲,数据分析不得有任何可能的标识。

Blinding:

Given the nature of the intervention, it is impossible to mask the participants or professionals to the study group assignments. However, data assessors will be blinded to participant study arm and data analysis will be blinded to any potential identifiers.

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

是Yes

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):

试验完成后6个月,采用网络平台:临床试验公共管理平台,网址:http://www.medresman.org。

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

The time of sharing IPD is within six months after the trial complete. Use web-based public database: ResMan and url: http://www.medresman.org.

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:

采用病例记录表和ResMan对数据采集和管理。

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

Conducting data collection and management by Case Record Form and ResMan.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-01
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