Application of Monitoring and Intervention Technologies in Suboptimal Health Status

NCT ID: NCT02441010

Last Updated: 2016-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2014 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Suboptimal Health Status Metabolic Abnormality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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 Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type SHAM_COMPARATOR

monitoring device

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

health information push technology

Intervention Type OTHER

The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.

monitoring device

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

monitoring device

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

health information push technology

Intervention Type OTHER

The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.

monitoring device

Intervention Type 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.

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.

Group Type EXPERIMENTAL

meridian therapy instrument

Intervention Type DEVICE

The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.

monitoring device

Intervention Type 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.

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.

Group Type EXPERIMENTAL

meridian therapy instrument

Intervention Type DEVICE

The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.

health information push technology

Intervention Type OTHER

The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.

monitoring device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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KangRu Health Management System BianQueFeiJiu

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Zeng, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Zeng, M.D

Role: STUDY_CHAIR

Chinese PLA General Hospital

Song Leng, M.D

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Dalian Medical University

Sheng-Yong Dong, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

General Staff Department of PLA

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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2012BAI37B04-05

Identifier Type: -

Identifier Source: org_study_id

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