Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,014
- 试验地点
- 2
- 主要终点
- the improvement of suboptimal health status
研究概览
简要总结
The purpose of this study is to use monitoring and intervention technologies in suboptimal health status in a general population in China and evaluate the effectiveness of these technologies in the improvement of suboptimal health status.
详细描述
The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.
A monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology. Intervention technologies include a health information push technology and a field-effect meridian therapy instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 60 years.
- •written informed consent.
排除标准
- •history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
- •history of mental illness.
- •pregnant or breastfeeding.
- •use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- •participation in another trial.
- •unable to promise to not use drugs and other fish oils during the study.
- •unable to provide informed written consent.
研究组 & 干预措施
Group 1
Participants without suboptimal health status are randomly grouped into the group without monitor (Group 1) and the monitor group (Group 2 or Group 3). Thus, no monitoring or intervention technologies are used in Group 1.
Group 2
Group 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.
干预措施: monitoring device (Device)
Group 3
Group 3 are participants with metabolic abnormality in the monitor group. Group 3 use the monitoring device and the health information push technology with three months.
干预措施: health information push technology (Other)
Group 3
Group 3 are participants with metabolic abnormality in the monitor group. Group 3 use the monitoring device and the health information push technology with three months.
干预措施: monitoring device (Device)
Group 4
All of participants with suboptimal health status use the monitoring device with three months, and are randomly grouped into the non-intervention group (Group 4 or Group 5) and the intervention group using the meridian therapy instrument (Group 6 or Group 7). Group 4 are participants without metabolic abnormality in the non-intervention group. No intervention technologies are used in Group 4.
干预措施: monitoring device (Device)
Group 5
Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
干预措施: health information push technology (Other)
Group 5
Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
干预措施: monitoring device (Device)
Group 6
Group 6 are participants without metabolic abnormality in the intervention group. Group 6 use the meridian therapy instrument with two weeks. If the suboptimal health status is not improved, then the meridian therapy instrument will continue to be used with an interval of one week.
干预措施: meridian therapy instrument (Device)
Group 6
Group 6 are participants without metabolic abnormality in the intervention group. Group 6 use the meridian therapy instrument with two weeks. If the suboptimal health status is not improved, then the meridian therapy instrument will continue to be used with an interval of one week.
干预措施: monitoring device (Device)
Group 7
Group 7 are participants with metabolic abnormality in the intervention group. Group 7 use the health information push technology with three months and the meridian therapy instrument with two weeks. Similar with Group 6, if the suboptimal health status is not improved after the treatment of the meridian therapy instrument, then the instrument will continue to be used with an interval of one week.
干预措施: meridian therapy instrument (Device)
Group 7
Group 7 are participants with metabolic abnormality in the intervention group. Group 7 use the health information push technology with three months and the meridian therapy instrument with two weeks. Similar with Group 6, if the suboptimal health status is not improved after the treatment of the meridian therapy instrument, then the instrument will continue to be used with an interval of one week.
干预措施: health information push technology (Other)
Group 7
Group 7 are participants with metabolic abnormality in the intervention group. Group 7 use the health information push technology with three months and the meridian therapy instrument with two weeks. Similar with Group 6, if the suboptimal health status is not improved after the treatment of the meridian therapy instrument, then the instrument will continue to be used with an interval of one week.
干预措施: monitoring device (Device)
结局指标
主要结局
the improvement of suboptimal health status
时间窗: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
次要结局
- the change of metabolic abnormality(three months)
研究者
Qiang Zeng, MD
Professor
Chinese PLA General Hospital