Clinical trial NCT02441010: Application of Monitoring and Intervention Technologies in Suboptimal Health Status
Official title: Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suboptimal Health Status
Metabolic Abnormality
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 2014
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the improvement of suboptimal health status
timeFrame: three months
Secondary outcomes:
measure: the change of metabolic abnormality
timeFrame: three months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: Chinese PLA General Hospital
name: Qiang Zeng, M.D
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital of Dalian Medical University
name: Song Leng, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: General Staff Department of PLA
name: Sheng-Yong Dong, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: