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Application of Monitoring and Intervention Technologies in Suboptimal Health Status

Not Applicable
Completed
Conditions
Suboptimal Health Status
Metabolic Abnormality
Interventions
Other: health information push technology
Device: meridian therapy instrument
Device: monitoring device
Registration Number
NCT02441010
Lead Sponsor
Chinese PLA General Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2014
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 3health information push technologyGroup 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 6meridian therapy instrumentGroup 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 4monitoring deviceAll 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 7meridian therapy instrumentGroup 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 7monitoring deviceGroup 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 5monitoring deviceGroup 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
Group 7health information push technologyGroup 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 2monitoring deviceGroup 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.
Group 3monitoring deviceGroup 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 5health information push technologyGroup 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.
Group 6monitoring deviceGroup 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.
Primary Outcome Measures
NameTimeMethod
the improvement of suboptimal health statusthree months

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

Secondary Outcome Measures
NameTimeMethod
the change of metabolic abnormalitythree 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).

Trial Locations

Locations (2)

Chinese PLA General Hospital

🇨🇳

Beijing, Beijing, China

The Second Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

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