Application of Monitoring and Intervention Technologies in Suboptimal Health Status

Not Applicable

Completed

• Conditions: Suboptimal Health Status; Metabolic Abnormality

• 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-03-18

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

Primary Outcome Measures

Name	Time	Method
the improvement of suboptimal health status	three months	The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.

Secondary Outcome Measures

Name	Time	Method
the change of metabolic abnormality	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).

Trial Locations

Locations (2)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China