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Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03335306
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Professor Cindy L.K. Lam, The University of Hong Kong
  Purpose

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.


Condition
Body Constitution

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

Further study details as provided by Professor Cindy L.K. Lam, The University of Hong Kong:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Short Form-36 (SF-36) Health-related quality of life of people with different constitution types [ Time Frame: Baseline only ]
  • Chinese quality of life (ChQOL) (HK version) Health-related quality of life of people with different constitution types [ Time Frame: Baseline only ]

Enrollment: 6400
Actual Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy subjects in Hong Kong

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335306


Locations
China, Hksar
The University of Hong Kong
Hong Kong, Hksar, China, 852
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
  More Information

Responsible Party: Professor Cindy L.K. Lam, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03335306     History of Changes
Other Study ID Numbers: HKCTR-1355
First Submitted: October 24, 2017
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Professor Cindy L.K. Lam, The University of Hong Kong:
Body constitution
Chinese Medicine
Validation