<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235336</url>
  </required_header>
  <id_info>
    <org_study_id>N1706-3431</org_study_id>
    <nct_id>NCT03235336</nct_id>
  </id_info>
  <brief_title>Associations Between Tea and Sweetened Beverage Consumptions and Hyperuricemia: The China Health and Nutrition Survey</brief_title>
  <official_title>The China Health and Nutrition Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The China Health and Nutrition Survey (CHNS), an ongoing open cohort, international&#xD;
      collaborative project between the Carolina Population Center at the University of North&#xD;
      Carolina at Chapel Hill and the National Institute for Nutrition and Health (NINH, former&#xD;
      National Institute of Nutrition and Food Safety) at the Chinese Center for Disease Control&#xD;
      and Prevention (CCDC), was designed to examine the effects of the health, nutrition, and&#xD;
      family planning policies and programs implemented by national and local governments and to&#xD;
      see how the social and economic transformation of Chinese society is affecting the health and&#xD;
      nutritional status of its population. The impact on nutrition and health behaviors and&#xD;
      outcomes is gauged by changes in community organizations and programs as well as by changes&#xD;
      in sets of household and individual economic, demographic, and social factors.&#xD;
&#xD;
      The survey was conducted by an international team of researchers whose backgrounds include&#xD;
      nutrition, public health, economics, sociology, Chinese studies, and demography. The survey&#xD;
      took place over a 7-day period using a multistage, random cluster process to draw a sample of&#xD;
      about 7,200 households with over 30,000 individuals in 15 provinces and municipal cities that&#xD;
      vary substantially in geography, economic development, public resources, and health&#xD;
      indicators. In addition, detailed community data were collected in surveys of food markets,&#xD;
      health facilities, family planning officials, and other social services and community&#xD;
      leaders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Survey Design&#xD;
&#xD;
      The survey covers nine provinces that vary substantially in geography, economic development,&#xD;
      public resources, and health indicators. A multistage, random cluster process was used to&#xD;
      draw the samples surveyed in each of the provinces. Counties in the nine provinces were&#xD;
      stratified by income (low, middle, and high), and a weighted sampling scheme was used to&#xD;
      randomly select four counties in each province. In addition, the provincial capital and a&#xD;
      lower income city were selected when feasible. In two provinces, other large cities had to be&#xD;
      selected. Villages and townships within the counties and urban and suburban neighborhoods&#xD;
      within the cities were selected randomly. In 1989 to 1993 there were 190 primary sampling&#xD;
      units, and a new province and its sampling units were added in 1997. There are about 4,400&#xD;
      households in the overall survey, covering some 19,000 individuals. Follow-up levels are&#xD;
      high, but families that migrate from one community to a new one are not followed. Movement&#xD;
      within the primary sampling units and some larger urban entities is attempted.&#xD;
&#xD;
      The first round of the CHNS, including household, community, and health/family planning&#xD;
      facility data, was collected in 1989. Six additional panels were collected in 1991, 1993,&#xD;
      1997, 2000, 2004, and 2006. Since the 1993 survey, all new households formed from sample&#xD;
      households were added. Since 1997, new households in original communities were also added to&#xD;
      replace households no longer participating in the study. Also since 1997, new communities in&#xD;
      original provinces have been added to replace sites no longer participating. A new province&#xD;
      was also added in 1997 when one province was unable to participate. The dropped province&#xD;
      returned to the study in 2000.&#xD;
&#xD;
      The Chinese Ministry of Public Health has committed to continue this project as long as&#xD;
      outside support is provided to supplement the extensive support it already provides. The&#xD;
      research project is truly a collaborative effort, with funding with funding, expertise, and&#xD;
      other skills shared equally by the American and Chinese institutions in significant&#xD;
      collaborative effort.&#xD;
&#xD;
      The Household Survey&#xD;
&#xD;
      A complete household roster has been used as a reference for subsequent blocks of questions&#xD;
      on time allocation at home (e.g., child care, elderly care, other key home activities) and&#xD;
      economic activities. Questions on income and time allocation probe for any possible activity&#xD;
      each person might have engaged in during the previous year, both in and out of the formal&#xD;
      market. Information on water sources, construction, condition of the home, and ownership of&#xD;
      consumer durables is gathered from the respondent. Additional questions probe for all&#xD;
      possible items the household might own. Full income from market and nonmarket activities is&#xD;
      imputed. The detailed estimation of income that is possible using these data represents a&#xD;
      significant advance in the measurement of income in China. Inclusion of nonmonetary&#xD;
      government subsidies such as state-subsidized housing is an especially important advance.&#xD;
&#xD;
      Health Services Section&#xD;
&#xD;
      The health services section contains detailed data on insurance coverage, medical providers,&#xD;
      and health facilities that the household might use under selected circumstances. Questions&#xD;
      about accessibility, time and travel costs, and perceived quality of care are asked.&#xD;
      Information on illnesses and on all uses of the health system during the previous month is&#xD;
      collected for children under age 7, for adults between age 20 and 45 in 1989, and from all&#xD;
      household members in later years. Questions on immunizations, use of preventive health&#xD;
      services, and use of family planning services are also asked.&#xD;
&#xD;
      Individual Survey&#xD;
&#xD;
      Since 2004, all questions that have related to individual activities, lifestyle, health&#xD;
      status, marriage and birth history, body shape, and mass media exposure, etc., have been&#xD;
      moved to two sets of individual questionnaires: for adults age 18 and older and for children&#xD;
      and adolescents under age 18. Children age 6 and above and all adults are asked to provide&#xD;
      their time allocation on household chores and child care, physical activities, and soft drink&#xD;
      and sugared fruit drink consumption. Youths age 12 and older and all adults are asked their&#xD;
      smoking status; consumption of tea, coffee, and alcohol; diet; and activity level.&#xD;
      Adolescents age 12 and older are asked to provide their conception of their body shape. Both&#xD;
      adolescents age 12 and older and women under age 52 married, divorced, remarried, or widowed&#xD;
      with children age 6 to 18 in household are asked about mass-media exposure. Women under age&#xD;
      52 and who are married, divorced, remarried, or widowed are asked to provide their marriage,&#xD;
      pregnancy, and birth history and inter-generational linkages to parents and parents-in-law.&#xD;
      Adults age 55 and older are asked to provide their daily living activities and were given a&#xD;
      memory test.&#xD;
&#xD;
      Nutrition &amp; Physical Examination&#xD;
&#xD;
      Three days' worth of detailed household food consumption information is collected. In&#xD;
      addition, individual dietary intake for three consecutive days is collected for every&#xD;
      household member, irrespective of age or relationship to the household head. Adults and&#xD;
      children receive detailed physical examinations that included weight, height, arm and head&#xD;
      circumference, mid-arm skinfold measurements, and blood pressure (for children age 7 and&#xD;
      older and all adults). Limited clinical nutrition and physical functioning data have been&#xD;
      collected since 1993. Activities of daily living and related information for older adults and&#xD;
      a new set of physical activity and inactivity data have been added for all respondents since&#xD;
      1997.&#xD;
&#xD;
      Community Survey&#xD;
&#xD;
      The community questionnaire (filled out for each of the primary sampling units) collects&#xD;
      information from a knowledgeable respondent on community infrastructure (water, transport,&#xD;
      electricity, communications, and so on), services (family planning, health facilities, retail&#xD;
      outlets), population, prevailing wages, and related variables.&#xD;
&#xD;
      Food Market Survey&#xD;
&#xD;
      In the first two surveys, state and free market data were collected. But by 1997, none of our&#xD;
      communities had separate state prices, so only free market stores and large stores have been&#xD;
      visited from then onward. In all cases, prices have been collected for a representative&#xD;
      basket of commodities.&#xD;
&#xD;
      Health and Family Planning Facility&#xD;
&#xD;
      In 1989, 1991, and 1993, separate visits were made to obtain in-depth data in each community&#xD;
      for every identified health service and family planning provider or facility. Information was&#xD;
      collected concerning personnel, sources of funds, services available, prices (asked&#xD;
      separately for insured and self-pay patients), and distance to the primary sampling units&#xD;
      served by the facility. A separate questionnaire was administered to the local family&#xD;
      planning official about family planning policies in the community. These were discontinued in&#xD;
      1997, but selected questions have been of these same personnel as part of the community&#xD;
      questionnaire since then.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1989</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hyperuricemia</measure>
    <time_frame>1997-2009</time_frame>
    <description>Serum uric acid level ≥420 μmol/L in males and ≥360 μmol/L in females</description>
  </primary_outcome>
  <enrollment type="Anticipated">5547</enrollment>
  <condition>Nutrition Poor</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study analyzed the participant data from the Chinese Health and Nutrition Survey&#xD;
        (CHNS, http://www.cpc.unc.edu/projects/china), which covered nine Chinese provinces&#xD;
        (Heilongjiang, Liaoning, Shandong, Henan, Jiangsu, Hubei, Hunan, Guizhou, and Guangxi). The&#xD;
        CHNS used a multistage random cluster sampling method.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  reported no endocrinal and rheumatological disease at baseline&#xD;
&#xD;
          -  provided valid responses regarding tea consumption, soft drink consumption, and&#xD;
             sweetened fruit drink consumption,&#xD;
&#xD;
          -  provided blood samples with valid serum uric acid data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Paul H Lee, PhD</last_name>
    <phone>34008275</phone>
    <email>paul.h.lee@polyu.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sichuan Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shufa Dr</last_name>
      <email>chns@unc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.cpc.unc.edu/projects/china</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Popkin BM, Du S, Zhai F, Zhang B. Cohort Profile: The China Health and Nutrition Survey--monitoring and understanding socio-economic and health change in China, 1989-2011. Int J Epidemiol. 2010 Dec;39(6):1435-40. doi: 10.1093/ije/dyp322. Epub 2009 Nov 3. No abstract available.</citation>
    <PMID>19887509</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_url>http://www.cpc.unc.edu/projects/china</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235336
org study id: N1706-3431
nct id: NCT03235336
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The China Health and Nutrition Survey (CHNS), an ongoing open cohort, international
      collaborative project between the Carolina Population Center at the University of North
      Carolina at Chapel Hill and the National Institute for Nutrition and Health (NINH, former
      National Institute of Nutrition and Food Safety) at the Chinese Center for Disease Control
      and Prevention (CCDC), was designed to examine the effects of the health, nutrition, and
      family planning policies and programs implemented by national and local governments and to
      see how the social and economic transformation of Chinese society is affecting the health and
      nutritional status of its population. The impact on nutrition and health behaviors and
      outcomes is gauged by changes in community organizations and programs as well as by changes
      in sets of household and individual economic, demographic, and social factors.

      The survey was conducted by an international team of researchers whose backgrounds include
      nutrition, public health, economics, sociology, Chinese studies, and demography. The survey
      took place over a 7-day period using a multistage, random cluster process to draw a sample of
      about 7,200 households with over 30,000 individuals in 15 provinces and municipal cities that
      vary substantially in geography, economic development, public resources, and health
      indicators. In addition, detailed community data were collected in surveys of food markets,
      health facilities, family planning officials, and other social services and community
      leaders.
Survey Design

      The survey covers nine provinces that vary substantially in geography, economic development,
      public resources, and health indicators. A multistage, random cluster process was used to
      draw the samples surveyed in each of the provinces. Counties in the nine provinces were
      stratified by income (low, middle, and high), and a weighted sampling scheme was used to
      randomly select four counties in each province. In addition, the provincial capital and a
      lower income city were selected when feasible. In two provinces, other large cities had to be
      selected. Villages and townships within the counties and urban and suburban neighborhoods
      within the cities were selected randomly. In 1989 to 1993 there were 190 primary sampling
      units, and a new province and its sampling units were added in 1997. There are about 4,400
      households in the overall survey, covering some 19,000 individuals. Follow-up levels are
      high, but families that migrate from one community to a new one are not followed. Movement
      within the primary sampling units and some larger urban entities is attempted.

      The first round of the CHNS, including household, community, and health/family planning
      facility data, was collected in 1989. Six additional panels were collected in 1991, 1993,
      1997, 2000, 2004, and 2006. Since the 1993 survey, all new households formed from sample
      households were added. Since 1997, new households in original communities were also added to
      replace households no longer participating in the study. Also since 1997, new communities in
      original provinces have been added to replace sites no longer participating. A new province
      was also added in 1997 when one province was unable to participate. The dropped province
      returned to the study in 2000.

      The Chinese Ministry of Public Health has committed to continue this project as long as
      outside support is provided to supplement the extensive support it already provides. The
      research project is truly a collaborative effort, with funding with funding, expertise, and
      other skills shared equally by the American and Chinese institutions in significant
      collaborative effort.

      The Household Survey

      A complete household roster has been used as a reference for subsequent blocks of questions
      on time allocation at home (e.g., child care, elderly care, other key home activities) and
      economic activities. Questions on income and time allocation probe for any possible activity
      each person might have engaged in during the previous year, both in and out of the formal
      market. Information on water sources, construction, condition of the home, and ownership of
      consumer durables is gathered from the respondent. Additional questions probe for all
      possible items the household might own. Full income from market and nonmarket activities is
      imputed. The detailed estimation of income that is possible using these data represents a
      significant advance in the measurement of income in China. Inclusion of nonmonetary
      government subsidies such as state-subsidized housing is an especially important advance.

      Health Services Section

      The health services section contains detailed data on insurance coverage, medical providers,
      and health facilities that the household might use under selected circumstances. Questions
      about accessibility, time and travel costs, and perceived quality of care are asked.
      Information on illnesses and on all uses of the health system during the previous month is
      collected for children under age 7, for adults between age 20 and 45 in 1989, and from all
      household members in later years. Questions on immunizations, use of preventive health
      services, and use of family planning services are also asked.

      Individual Survey

      Since 2004, all questions that have related to individual activities, lifestyle, health
      status, marriage and birth history, body shape, and mass media exposure, etc., have been
      moved to two sets of individual questionnaires: for adults age 18 and older and for children
      and adolescents under age 18. Children age 6 and above and all adults are asked to provide
      their time allocation on household chores and child care, physical activities, and soft drink
      and sugared fruit drink consumption. Youths age 12 and older and all adults are asked their
      smoking status; consumption of tea, coffee, and alcohol; diet; and activity level.
      Adolescents age 12 and older are asked to provide their conception of their body shape. Both
      adolescents age 12 and older and women under age 52 married, divorced, remarried, or widowed
      with children age 6 to 18 in household are asked about mass-media exposure. Women under age
      52 and who are married, divorced, remarried, or widowed are asked to provide their marriage,
      pregnancy, and birth history and inter-generational linkages to parents and parents-in-law.
      Adults age 55 and older are asked to provide their daily living activities and were given a
      memory test.

      Nutrition & Physical Examination

      Three days' worth of detailed household food consumption information is collected. In
      addition, individual dietary intake for three consecutive days is collected for every
      household member, irrespective of age or relationship to the household head. Adults and
      children receive detailed physical examinations that included weight, height, arm and head
      circumference, mid-arm skinfold measurements, and blood pressure (for children age 7 and
      older and all adults). Limited clinical nutrition and physical functioning data have been
      collected since 1993. Activities of daily living and related information for older adults and
      a new set of physical activity and inactivity data have been added for all respondents since
      1997.

      Community Survey

      The community questionnaire (filled out for each of the primary sampling units) collects
      information from a knowledgeable respondent on community infrastructure (water, transport,
      electricity, communications, and so on), services (family planning, health facilities, retail
      outlets), population, prevailing wages, and related variables.

      Food Market Survey

      In the first two surveys, state and free market data were collected. But by 1997, none of our
      communities had separate state prices, so only free market stores and large stores have been
      visited from then onward. In all cases, prices have been collected for a representative
      basket of commodities.

      Health and Family Planning Facility

      In 1989, 1991, and 1993, separate visits were made to obtain in-depth data in each community
      for every identified health service and family planning provider or facility. Information was
      collected concerning personnel, sources of funds, services available, prices (asked
      separately for insured and self-pay patients), and distance to the primary sampling units
      served by the facility. A separate questionnaire was administered to the local family
      planning official about family planning policies in the community. These were discontinued in
      1997, but selected questions have been of these same personnel as part of the community
      questionnaire since then.
observational model: Cohort
time perspective: Prospective
measure: Hyperuricemia
time frame: 1997-2009
description: Serum uric acid level ≥420 μmol/L in males and ≥360 μmol/L in females
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Paul H Lee, PhD
phone: 34008275
email: paul.h.lee@polyu.edu.hk
facility: 
status: Recruiting
contact: 
country: China
url: http://www.cpc.unc.edu/projects/china
description: Related Info
citation: Popkin BM, Du S, Zhai F, Zhang B. Cohort Profile: The China Health and Nutrition Survey--monitoring and understanding socio-economic and health change in China, 1989-2011. Int J Epidemiol. 2010 Dec;39(6):1435-40. doi: 10.1093/ije/dyp322. Epub 2009 Nov 3. No abstract available.
PMID: 19887509
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: Yes
ipd url: http://www.cpc.unc.edu/projects/china