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【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
ChiCTR2400080248
尚未开始
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2024-01-24
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NCDs
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
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
0000
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.
随机平行对照
Ⅰ期
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.
The primary investigator will be blinded from the allocation. While the participants and intervention deliverers (The health coaches) will not be blinded.
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500
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2024-03-01
2025-09-30
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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.；
登录查看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.；
登录查看JC School of Public Health and Primary Care, CUHK
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JC School of Public Health and Primary Care, CUHK的其他临床试验
- Personalised Lifestyle Medicine in Mid-life Project
- Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms randomized controlled trial
- 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
JC School of Public Health and Primary Care, CUHK的其他临床试验
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