Application of Monitoring and Intervention Technologies in Suboptimal Health Status

Suboptimal Health Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441010
• Other study ID #: 2012BAI37B04-05
• Status: Completed
• Phase: N/A
• First received: May 1, 2015
• Last updated: March 17, 2016
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2014
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Abnormality
• Suboptimal Health Status

Intervention

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:
• 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.

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	The Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	three months	No