Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

NCT03335306 | Completed DMC

• 1 other identifier: HKCTR-1355
• Study Type: observational
• Target: 6,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Constitution

Keywords

Body constitution; Chinese Medicine; Validation

Outcome Measures

Primary Outcomes (1)

• Prevalence of constitution types classified by the BCQ or CCMQ

  Proportion of different constitution types according to the BCQ or CCMQ questionnaire

  Baseline only

Secondary Outcomes (2)

• Short Form-12 (SF-12) Health-related quality of life of people with different constitution types

  Baseline only

• Chinese quality of life (ChQOL) (HK version) Health-related quality of life of people with different constitution types

  Baseline only

Study Arms (1)

Healthy subjects in Hong Kong

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The University of Hong Kong: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hksar, 852, China

Location

Study Officials

• Wendy Wong, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CN (1)