ChiCTR2400080248
尚未招募
1 期
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
未提供4 个研究点 分布在 1 个国家开始时间: 2024年3月1日最近更新:
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 试验地点
- 4
- 主要终点
- Blood biochemical (FBG, TC, HDL, LDL, TG)
概览
简要总结
The primary objectives of this RCT are to confirm:
- 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)
- 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:
- 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)
- To compare the effectiveness of combined interventions (HC + HW) versus HC-only and HW-only respectively.
- To compare the effectiveness of HC-only vs HW-only intervention.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 35 至 59（—）
- 性别
- All
入选标准
- •Aged between 35 –
- •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
- •Not aged between 35 –
- •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.
研究组 & 干预措施
Health coaching + Smart watch intervention group
Health coaching intervention group
Smart watch intervention group
Waitlist control group
结局指标
主要结局
Blood biochemical (FBG, TC, HDL, LDL, TG)
时间窗: Baseline and 6 months
Blood pressure
时间窗: Baseline and 6 months
Heart rate, Steps count, Frequency of Physical activity, Sleeping quality score
时间窗: Within 6 months of the intervention period
次要结局
- Alcohol use (by AUDIT-C)(Baseline and 6 months)
- Diet(Baseline, 3 months and 6 months after intervention)
- Physical activity level (by IPAQ-SF)(Baseline, 3 months and 6 months after intervention)
- Health-related Quality of life (By EQ5D)(Baseline, 3 months and 6 months after intervention)
- Sleep quality and disturbances (By PSQI)(Baseline, 3 months and 6 months after intervention)
- Perceived stress (By PSS-10)(Baseline, 3 months and 6 months after intervention)
- Anxiety (By GAD-7)(Baseline, 3 months and 6 months after intervention)
- Depression (By PHQ-9)(Baseline, 3 months and 6 months after intervention)
- Satisfactory of life(Baseline, 3 months and 6 months after intervention)
- Social media addiction (BSMAS)(Baseline, 3 months and 6 months after intervention)
- Loneliness (By 6-item De Jong Gierveld Loneliness Scale)(Baseline, 3 months and 6 months after intervention)
- Self-efficacy (By 10-item General Self Efficacy Scale)(Baseline, 3 months and 6 months after intervention)
- e-health literacy (By 8-item eHealth Literacy Scale)(Baseline, 3 months and 6 months after intervention)
- Body composition(Baseline and 6 months)
- Demographic and CVD risk exposure data(Baseline, 3 months and 6 months after intervention)
研究者
研究点 (4)
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