Clinical trial NCT03335306: Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Official title: Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Constitution
Keywords: Body constitution
Chinese Medicine
Validation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Hospital Authority, Hong Kong
First posted: 2017-11-07
Enrollment: 6400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Prevalence of constitution types classified by the BCQ or CCMQ
timeFrame: Baseline only
Secondary outcomes:
measure: Short Form-12 (SF-12) Health-related quality of life of people with different constitution types
timeFrame: Baseline only
measure: Chinese quality of life (ChQOL) (HK version) Health-related quality of life of people with different constitution types
timeFrame: Baseline only
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hksar
Study officials:
affiliation: Chinese University of Hong Kong
name: Wendy Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: