Suboptimal Health StatusNCT02441010
Application of Monitoring and Intervention Technologies in Suboptimal Health Status
A study testing meridian therapy instrument, health information push technology and monitoring device in people with Suboptimal Health Status and Metabolic Abnormality, run by Chinese PLA General Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Suboptimal Health Status, Metabolic Abnormality
- What is being tested?
- meridian therapy instrument, health information push technology and monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,014 participants
- Where
- 2 sitesChina
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 60 years.
- written informed consent.
Who cannot join
- 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.
- history of mental illness.
- pregnant or breastfeeding.
- use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- participation in another trial.
- unable to promise to not use drugs and other fish oils during the study.
- unable to provide informed written consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
About this study
Official title: Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China
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.
Read the 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.
- Conditions
- Suboptimal Health Status, Metabolic Abnormality
- Being tested
- meridian therapy instrument, health information push technology, monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meridian therapy instrumentDevice
Also called KangRu
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 technologyOther
Also called Health Management System
The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
monitoring deviceDevice
Also called BianQueFeiJiu
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | 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 2 | Sham comparator | Group 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months. Receives: Device: monitoring device |
| Group 3 | Sham comparator | 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. Receives: Other: health information push technology; Device: monitoring device |
| Group 4 | Active comparator | 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. Receives: Device: monitoring device |
| Group 5 | Active comparator | Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months. Receives: Other: health information push technology; Device: monitoring device |
| Group 6 | Experimental | 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. Receives: Device: meridian therapy instrument; Device: monitoring device |
| Group 7 | Experimental | 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. Receives: Device: meridian therapy instrument; Other: health information push technology; Device: monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of suboptimal health status
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
Measured: three months
Secondary outcomes (1)
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).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suboptimal Health StatusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zeng, MD, Chinese PLA General Hospital
- Investigators
- Qiang Zeng, M.D, Study chair, Chinese PLA General HospitalSong Leng, M.D, Principal investigator, The Second Affiliated Hospital of Dalian Medical UniversitySheng-Yong Dong, M.D., Ph.D, Principal investigator, General Staff Department of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441010
- Sponsor's protocol ID
- 2012BAI37B04-05
- Status last verified
- Mar 2016
- First submitted
- 1 May 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Monitoring and Intervention Technologies in Suboptimal Health Status in a General Population in China
- ClinicalTrials.gov ID
- NCT02441010
- Acronym / sponsor ID
- 2012BAI37B04-05
- Conditions
- Suboptimal Health Status, Metabolic Abnormality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –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 2 | Sham comparator | Device: monitoring deviceGroup 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months. |
| Group 3 | Sham comparator | Other: health information push technology, Device: monitoring 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 4 | Active comparator | Device: monitoring 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 5 | Active comparator | Other: health information push technology, Device: monitoring deviceGroup 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months. |
| Group 6 | Experimental | Device: meridian therapy instrument, Device: monitoring 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. |
| Group 7 | Experimental | Device: meridian therapy instrument, Other: health information push technology, Device: monitoring 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 60 years.
- written informed consent.
Key exclusion criteria (7 listed)
- 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.
- history of mental illness.
- pregnant or breastfeeding.
- use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- participation in another trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meridian therapy instrumentAlso: KangRuThe meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect. | Device | Group 6, Group 7 |
| health information push technologyAlso: Health Management SystemThe health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle. | Other | Group 3, Group 5, Group 7 |
| monitoring deviceAlso: BianQueFeiJiuThe monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology. | Device | Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
Primary outcome
the improvement of suboptimal health status
Time frame: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
1 secondary outcome
the change of metabolic abnormality
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Zeng, M.D study chair
Chinese PLA General Hospital
Song Leng, M.D principal investigator
The Second Affiliated Hospital of Dalian Medical University
Sheng-Yong Dong, M.D., Ph.D principal investigator
General Staff Department of PLA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meridian therapy instrument, health information push technology and monitoring device in people with Suboptimal Health Status and Metabolic Abnormality, run by Chinese PLA General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the improvement of suboptimal health status (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.