Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

January 7, 2018 updated by: Wendy Wong, Chinese University of Hong Kong

Background: Different people are classified into different physiological constitution types in the Traditional Chinese Medicine (TCM) theory. Two instruments, the Body Constitution Questionnaire (BCQ) and the Constitution in Chinese Medicine Questionnaire (CCMQ), have been developed in Taiwan and Mainland China respectively to measure constitution. They were adapted and pilot tested in primary care Chinese patients in Hong Kong, which showed acceptable validity and reliability. These instruments have potential applications for epidemiological studies on body constitution.

Aim and objectives: The aim of this study is to establish the prevalence and epidemiology of body constitution classified by the Traditional Chinese Medicine Theory in the Chinese population in Hong Kong. It would also determine whether the prevalence of constitution types change with seasons and whether it is associated with socio-demographic factors, place of origin or residence, life style, or quality of life.

Design and subjects: Two cross-sectional telephone surveys of the Hong Kong (HK) general Chinese population, one in Summer and one in Winter, will be carried out. Sample size for each survey is 3200 subjects.

Methods: Residential-telephone-owning households will be contacted through random dialing by the Social Science and Research Centre of the University of Hong Kong using the Computer-Assisted Telephone Interviewing (CATI) system that covers 95% households in Hong Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday will be invited to the study to answer either the BCQ or the CCMQ and a structured questionnaire on socio-demographics, place of origin, place of residence, health service utilization, life style and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hksar
      • Hong Kong, Hksar, China, 852
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Methods: Residential-telephone-owning households will be contacted through random dialing by the Social Science and Research Centre of the University of Hong Kong using the CATI system that covers 95% households in Hong Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday will be invited to the study to answer either the BCQ or the CCMQ and a structured questionnaire on socio-demographics, place of origin, place of residence, health service utilization, life style and quality of life.

Description

Inclusion Criteria:

  • Can be contacted by in a residential telephone number
  • Age 18 or above
  • Chinese who can communicate in Cantonese or Chinese by telephone;
  • Has given verbal consent to take part in the study

Exclusion Criteria:

  • Cannot communicate in Cantonese or Chinese
  • Persons who cannot communicate by telephone;
  • Refuse to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy subjects in Hong Kong

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of constitution types classified by the BCQ or CCMQ
Time Frame: Baseline only
Proportion of different constitution types according to the BCQ or CCMQ questionnaire
Baseline only

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Short Form-12 (SF-12) Health-related quality of life of people with different constitution types
Time Frame: Baseline only
Baseline only
Chinese quality of life (ChQOL) (HK version) Health-related quality of life of people with different constitution types
Time Frame: Baseline only
Baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
Hospital Authority, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wendy Wong, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HKCTR-1355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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