Nine Body ConstitutionsNCT04776460
The Distribution of Body Constitutions Among Hong Kong Elderly Population: A Cross-sectional Study
An observational study of Nine Body Constitutions, run by Hong Kong Baptist University at 1 site in China.
Trial summary
Hong Kong, similar as other developed economic entities, has been faced big challenges from increasing medical burden and aged population. Based on the updated estimates of domestic health expenditure by Food and Health Bureau HKSAR, the total health expenditure amounted to HK$112,144 million in 2012/13 with… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nine Body Constitutions
- How many people
- 5,300 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2020to 3 Feb 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study will select the populations of aged 65 and over as subjects. We aims to cover 0.5% of these population and then 5,300 participants will be recruited from public. The random core sample will be obtained using stratified random sampling, where residential address will be randomly sampled in all 18 districts in Hong Kong with sample size proportionate to each of the district populations. We will invite them to enroll in our Chinese medicine preventive study and consent form will also be sent by mail, email and Whatsapp Business.
Who may be able to join
- aged 65 and over
- capable of consenting and have agreed to participate, ambulatory, and not receiving treatment modalities, which, if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure
Who cannot join
- neurological disorders such as dementia
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong
About this study
Hong Kong, similar as other developed economic entities, has been faced big challenges from increasing medical burden and aged population. Based on the updated estimates of domestic health expenditure by Food and Health Bureau HKSAR, the total health expenditure amounted to HK$112,144 million in 2012/13 with increasing approximate 4 times than 1992/93. According to the data from Census and Statistics Department, in 2010, there was still 13% population aged above 65 years, while in 2039, this percentage will be elevated to 28% (http://www.censtatd.gov.hk/hkstat/sub/so20.jsp). In other words, every three individuals will contain a person aged above 65 years in the future 30 years. Therefore, how to release the medical burden resulted from aged tendency of population is the critical question in optimizing the treatment expenses.
Our aims in the cross-sectional study are to 1) estimate the number and percentage of nine body constitutions among population aged 65 and over in Hong Kong 2) identify the associations between nine body constitutions and other predetermined factors such as gender, weight, diet, body mass index (BMI), blood pressure, quality of life scale scores, et al.
- Conditions
- Nine Body Constitutions
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of nine body constitutions assessed by the TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version)
The primary outcome will be the distribution of nine body constitutions in Hong Kong aged 65 and over population.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Correlation between body constitution distribution and other predetermined factors
Secondary outcomes will be the correlation between body constitution distribution and other predetermined factors such as gender, age, weight, dietary habit, education and quality of life scores (SF-36 Hong Kong questionnaire), et al.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start29 Apr 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nine Body ConstitutionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Zhao-xiang Bian, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776460
- Sponsor's protocol ID
- HKBU JC 004
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distribution of Body Constitutions Among Hong Kong Elderly Population: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04776460
- Acronym / sponsor ID
- HKBU JC 004
- Conditions
- Nine Body Constitutions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,300 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- 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.
Hong Kong, similar as other developed economic entities, has been faced big challenges from increasing medical burden and aged population. Based on the updated estimates of domestic health expenditure by Food and Health Bureau HKSAR, the total health expenditure amounted to HK$112,144 million in 2012/13 with increasing approximate 4 times than 1992/93. According to the data from Census and Statistics Department, in 2010, there was still 13% population aged above 65 years, while in 2039, this percentage will be elevated to 28% (http://www.censtatd.gov.hk/hkstat/sub/so20.jsp). In other words, every three individuals will contain a person aged above 65 years in the future 30 years. Therefore, how to release the medical burden resulted from aged tendency of population is the critical question in optimizing the treatment expenses.
Our aims in the cross-sectional study are to 1) estimate the number and percentage of nine body constitutions among population aged 65 and over in Hong Kong 2) identify the associations between nine body constitutions and other predetermined factors such as gender, weight, diet, body mass index (BMI), blood pressure, quality of life scale scores, et al.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study will select the populations of aged 65 and over as subjects. We aims to cover 0.5% of these population and then 5,300 participants will be recruited from public. The random core sample will be obtained using stratified random sampling, where residential address will be randomly sampled in all 18 districts in Hong Kong with sample size proportionate to each of the district populations. We will invite them to enroll in our Chinese medicine preventive study and consent form will also be sent by mail, email and Whatsapp Business.
Key inclusion criteria (2 listed)
- aged 65 and over
- capable of consenting and have agreed to participate, ambulatory, and not receiving treatment modalities, which, if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure
Key exclusion criteria (1 listed)
- neurological disorders such as dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of nine body constitutions assessed by the TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version)
Time frame: through study completion, an average of 1 year
The primary outcome will be the distribution of nine body constitutions in Hong Kong aged 65 and over population.
1 secondary outcome
Correlation between body constitution distribution and other predetermined factors
Time frame: through study completion, an average of 1 year
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 1 Mar 2021.
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.
Zhao-xiang Bian, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nine Body Constitutions, run by Hong Kong Baptist University at 1 site 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 1 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Distribution of nine body constitutions assessed by the TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version) (time frame: through study completion, an average of 1 year). 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 1 Mar 2021.