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Application of Monitoring and Intervention Technologies in Suboptimal Health Status

Primary Purpose

Suboptimal Health Status, Metabolic Abnormality

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
meridian therapy instrument
health information push technology
monitoring device
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suboptimal Health Status

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age between 18 and 60 years.
  2. written informed consent.

Exclusion Criteria:

  1. 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.
  2. history of mental illness.
  3. pregnant or breastfeeding.
  4. use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
  5. participation in another trial.
  6. unable to promise to not use drugs and other fish oils during the study.
  7. unable to provide informed written consent.

Sites / Locations

  • Chinese PLA General Hospital
  • The Second Affiliated Hospital of Dalian Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Sham Comparator

Sham Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Group 7

Arm Description

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 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.

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.

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.

Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.

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.

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.

Outcomes

Primary Outcome Measures

the improvement of suboptimal health status
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.

Secondary Outcome Measures

the change of metabolic abnormality
To investigate the change of metabolic abnormality when the monitoring and/or intervention technologies are used. The definition of metabolic abnormality is met when one or more of the following criteria are present: (1) blood pressure ≥ 130 mmHg; (2) fasting blood glucose ≥ 100 mg/dl; (3) body mass index ≥ 28 kg/m2; (4) dyslipidemia (total cholesterol ≥ 200 mg/dl, triglyceride ≥ 150 mg/dl, low-density lipoprotein cholesterol ≥ 130 mg/dl, and/or high-density lipoprotein cholesterol < 40 mg/dl).

Full Information

First Posted
May 1, 2015
Last Updated
March 17, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02441010
Brief Title
Application of Monitoring and Intervention Technologies in Suboptimal Health Status
Official Title
Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suboptimal Health Status, Metabolic Abnormality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2014 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
Group 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.
Arm Title
Group 3
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
Arm Title
Group 6
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 7
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
meridian therapy instrument
Other Intervention Name(s)
KangRu
Intervention Description
The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.
Intervention Type
Other
Intervention Name(s)
health information push technology
Other Intervention Name(s)
Health Management System
Intervention Description
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
Intervention Type
Device
Intervention Name(s)
monitoring device
Other Intervention Name(s)
BianQueFeiJiu
Intervention Description
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.
Primary Outcome Measure Information:
Title
the improvement of suboptimal health status
Description
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
Time Frame
three months
Secondary Outcome Measure Information:
Title
the change of metabolic abnormality
Description
To investigate the change of metabolic abnormality when the monitoring and/or intervention technologies are used. The definition of metabolic abnormality is met when one or more of the following criteria are present: (1) blood pressure ≥ 130 mmHg; (2) fasting blood glucose ≥ 100 mg/dl; (3) body mass index ≥ 28 kg/m2; (4) dyslipidemia (total cholesterol ≥ 200 mg/dl, triglyceride ≥ 150 mg/dl, low-density lipoprotein cholesterol ≥ 130 mg/dl, and/or high-density lipoprotein cholesterol < 40 mg/dl).
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 18 and 60 years. written informed consent. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Zeng, M.D
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Song Leng, M.D
Organizational Affiliation
The Second Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheng-Yong Dong, M.D., Ph.D
Organizational Affiliation
General Staff Department of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

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Application of Monitoring and Intervention Technologies in Suboptimal Health Status

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