【ChiCTR2400080248】Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

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基本信息

登记号

ChiCTR2400080248

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2024-01-24

临床申请受理号

靶点

适应症

NCDs

试验通俗题目

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

试验专业题目

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms adaptive randomized controlled trial

申办单位信息

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申请人名称

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联系人邮编

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临床试验信息

试验目的

The primary objectives of this RCT are to confirm: 1. The effectiveness of health coaching (HC) + health watch (HW) intervention versus waitlist group on lipid profiles, glucose level, and blood pressures, and risk of having CVD (defined by QRisk) 2. The effectiveness of the effect of HC-only intervention versus waitlist group and the effect of HW-only versus waitlist group on lipid, glucose, blood pressure, and risk of having CVD (defined by QRisk) The secondary objectives are exploratorily basis: 1. The effectiveness of the interventions listed in the primary objectives on secondary outcomes (lifestyle measures such as physical activities, food consumption, and alcohol and smoking consumptions) 2. To compare the effectiveness of combined interventions (HC + HW) versus HC-only and HW-only respectively. 3. To compare the effectiveness of HC-only vs HW-only intervention.

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

2,000 subjects will be recruited into the 4-arm design of the RCT. The number of subjects in each arm will be distributed in 1:1:1:1 ratio (250 subjects for each arm). These subjects will be distributed to 7 centres out of 4 NGOs equally. Block randomization by centres will be performed to balance the number of subjects in each arm per centre. An interim analysis will then be performed to assess whether the effect of the objectives have been determined. If the effect has been determined, then the remaining 1000 participants will be randomized into the 4 groups in the same manner. If not, the control group will be taken out, so that the remaining 1000 participants will be randomized into the remaining 3 treatment arms in 1:1:1 ratio. The randomization sequence will be generated by an independent statistician.

盲法

The primary investigator will be blinded from the allocation. While the participants and intervention deliverers (The health coaches) will not be blinded.

试验项目经费来源

试验范围

目标入组人数

500

实际入组人数

第一例入组时间

2024-03-01

试验终止时间

2025-09-30

是否属于一致性

入选标准

1) Aged between 35 – 59. 2) Without doctor-diagnosed chronic diseases and require medication (including diabetes, hypertension, cardiovascular diseases, chronic obstructive pulmonary diseases, depression, autoimmune diseases, and cancer). 3) Not in the waiting list for follow-up healthcare services in the public or private sector because of the listed chronic diseases above. 4) Not a member of district health centre to reduce overlapping of community resources.；

排除标准

1) Not aged between 35 – 59. 2) With doctor-diagnosed chronic diseases and require medication (including diabetes, hypertension, cardiovascular diseases, chronic obstructive pulmonary diseases, depression, autoimmune diseases, and cancer). 3) In the waiting list for follow-up healthcare services in the public or private sector because of the listed chronic diseases above. 4) A member of district health centre. 5) Those who cannot provide consent. 6) Pregnant woman. 7) Does not understand Cantonese.；

研究者信息

研究负责人姓名

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试验机构

JC School of Public Health and Primary Care, CUHK

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研究负责人邮编

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联系人通讯地址