Application of Monitoring and Intervention Technologies in Suboptimal Health Status

March 17, 2016 updated by: Qiang Zeng, MD, Chinese PLA General Hospital

Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2014

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
    • Liaoning
      • Dalian, Liaoning, China
        • The Second Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Sham Comparator: Group 2
Group 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Sham Comparator: 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.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Other: health information push technology
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
Other Names:
  • Health Management System
Active Comparator: 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.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Active Comparator: 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.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Other: health information push technology
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
Other Names:
  • Health Management System
Experimental: 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.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Device: meridian therapy instrument
The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.
Other Names:
  • KangRu
Experimental: 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.
Device: monitoring device
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.
Other Names:
  • BianQueFeiJiu
Other: health information push technology
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
Other Names:
  • Health Management System
Device: meridian therapy instrument
The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.
Other Names:
  • KangRu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the improvement of suboptimal health status
Time Frame: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of metabolic abnormality
Time Frame: three months
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).
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012BAI37B04-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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