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【ChiCTR1800014885】An educational program for Hong Kong Chinese post-menopausal women

基本信息
登记号

ChiCTR1800014885

试验状态

尚未开始

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2018-02-12

临床申请受理号

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靶点

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适应症

超重或肥胖

试验通俗题目

An educational program for Hong Kong Chinese post-menopausal women

试验专业题目

A theory-based educational program to improve the cardiovascular health among Hong Kong Chinese post-menopausal women

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

1) To examine the effects of the educational intervention on knowledge of CV health, self-efficacy and exercise, and physical activity and dietary pattern; 2) To examine if the effects of the intervention on physical activity and dietary pattern are mediated through knowledge of CV health, and self-efficacy in diet and exercise; 3) To examine if a positive change in physical activity and dietary pattern can result in improvements on CV health outcomes (body weight, body fat mass percentage, WC, CVD risk, fasting blood glucose, lipid profile, high sensitivity CRP, adiponectin, and IGF-1), sleep quality and vasomotor symptoms among overweight Chinese post-menopausal women in Hong Kong.

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

After collecting baseline data, eligible participants will be randomly allocated to intervention or control group using a computer-generated random number sequence prepared by an independent statistician.

盲法

The research assistant responsible for data collection will be blinded for group allocations of participants.

试验项目经费来源

General Research Fund, Hong Kong

试验范围

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目标入组人数

144

实际入组人数

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第一例入组时间

2018-01-01

试验终止时间

2020-08-31

是否属于一致性

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入选标准

1) Chinese post-menopausal women aged ≤65 years [post-menopause is defined as experience of amenorrhea not attributing to other causes for at least 12 months13]; 2) Being overweight or obese (BMI > 22.9 kg/m2) or with central obesity (WC > 80cm)41; 3) Able to give informed consent; 4) Attain at least 6 years of formal education.；

排除标准

1) Being diagnosed with any cardiovascular disease; 2) Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program; 3) Concurrently using hormonal replacement therapy; 4) Known history of psychiatric disorders.；

研究者信息
研究负责人姓名
试验机构

香港中文大學那打素護理學院

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址

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