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Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

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.
 
ClinicalTrials.gov Identifier: NCT03335306
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
The University of Hong Kong
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Wendy Wong, Chinese University of Hong Kong

Tracking Information
First Submitted Date October 24, 2017
First Posted Date November 7, 2017
Last Update Posted Date January 9, 2018
Actual Study Start Date July 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2018)
  • Short Form-12 (SF-12) 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 ]
Original Secondary Outcome Measures
 (submitted: November 2, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Official Title Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Body Constitution
Intervention Not Provided
Study Groups/Cohorts Healthy subjects in Hong Kong
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 2, 2017)
6400
Original Actual Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03335306
Other Study ID Numbers HKCTR-1355
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wendy Wong, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators
  • The University of Hong Kong
  • Hospital Authority, Hong Kong
Investigators
Principal Investigator: Wendy Wong, PhD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date January 2018