Application of Monitoring and Intervention Technologies in Suboptimal Health Status
1 other identifier
interventional
2,014
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 18, 2016
March 1, 2016
1.4 years
May 1, 2015
March 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
the improvement of suboptimal health status
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
three months
Secondary Outcomes (1)
the change of metabolic abnormality
three months
Study Arms (7)
Group 1
NO INTERVENTIONParticipants 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
SHAM COMPARATORGroup 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.
Group 3
SHAM COMPARATORGroup 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.
Group 4
ACTIVE COMPARATORAll 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.
Group 5
ACTIVE COMPARATORGroup 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
Group 6
EXPERIMENTALGroup 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.
Group 7
EXPERIMENTALGroup 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.
Interventions
The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
The monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology.
Eligibility Criteria
You may qualify if:
- age between 18 and 60 years.
- written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qiang Zeng, M.D
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Song Leng, M.D
The Second Affiliated Hospital of Dalian Medical University
- PRINCIPAL INVESTIGATOR
Sheng-Yong Dong, M.D., Ph.D
General Staff Department of PLA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 12, 2015
Study Start
May 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 18, 2016
Record last verified: 2016-03