<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/NCT03292055</url>
  </required_header>
  <id_info>
    <org_study_id>2016.557</org_study_id>
    <nct_id>NCT03292055</nct_id>
  </id_info>
  <brief_title>Food Frequency Questionnaire (FFQ) for Coronary Heart Disease (CHD) Patients</brief_title>
  <official_title>Evaluation of the Psychometric Properties of a Food Frequency Questionnaire Developed for Patients With Coronary Heart Disease in Northern China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      This study aims to evaluate the psychometric properties of a newly developed FFQ specified&#xD;
      for northern Chinese CHD and their high risk patients (CHD-FFQ). The psychometric properties&#xD;
      include test-retest reliability, content validity, convergent validity, discriminant&#xD;
      validity, concurrent validity and predictive validity. Particularly, this study will measure&#xD;
      the physiological indicators, including plasma lipid profile (i.e. TG, TC, HDL-C, LDL-C), BG,&#xD;
      BP and BMI twice at baseline and the end. The level of these physiological indicators will be&#xD;
      compared with the fat intake measured by the CHD-FFQ, i.e. the baseline intake to test its&#xD;
      convergent validity. It is also expected to predict the diet-related progression of CHD risks&#xD;
      among high-risk individuals, i.e. patients with two or more CHD risk factors as following:&#xD;
      raised fasting blood glucose (BG) level, increased blood pressure (BP), increased&#xD;
      triglycerides (TG), decreased HDL-Cholesterol (HDL-C), increased LDL-Cholesterol (LDL-C),&#xD;
      smoking and central obesity (International Diabetes Federation, 2015). In addition, this&#xD;
      study will provide the FFQ's concurrent validity in assessing the intake of energy and&#xD;
      nutrients against the CDC-FFQ. Moreover, whether the FFQ could detect the known differences&#xD;
      in energy intake between men and women will be established for its discriminant validity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Intake of Food</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>The newly developed FFQ (CHD-FFQ) will be applied to the participants to collect their dietary intake of food.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac-related physiological blood parameters</measure>
    <time_frame>January- February, October- November</time_frame>
    <description>In the beginning and the end of the study, the medical records of the participants will be refered to get the blood glucose, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in the past three months, in the department and the community centers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>Participant's height will be measured to the nearest 0.5 cm, with a right-angle triangle resting on the scalp and against the wall, having the back square against the wall tape and eyes looking straight ahead. The height will be measured without wearing shoes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>A calibrated scale with the resolution of 0.1 kg will be used to measure the weight of the participants, who will be asked to wear light clothes during measurement. The weight will be measured without shoes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumstance</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>Waist circumstance will be taken at the midpoint between the top of the iliac crest and the lower margin of the palpable rib</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>To take the blood pressure, the participant will be asked to be seated for at least 15 minutes with his/her legs uncrossed (WHO, 2008). Two BP measurements will be taken and between the two readings, the participant will have three minutes' rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intake of Food</measure>
    <time_frame>October-November</time_frame>
    <description>As a criterion, the FFQ developed by Chinese CDC will be applied to the participants to collect their dietary intake of food.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic information</measure>
    <time_frame>January-February</time_frame>
    <description>Age, gender, marital status, occupation, educational level, living conditions, financial background, and living areas will be collected using a self-developed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General clinical information</measure>
    <time_frame>January-February</time_frame>
    <description>Smoking history, family history and clinical data will be collected using a self-developed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Information</measure>
    <time_frame>October- November</time_frame>
    <description>Their clinical information on hospital readmission, surgery or medical procedures, and medication adjustment during the last year will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>January-February, April- May, July- August, October- November</time_frame>
    <description>The physical activity level of the participants will be measured using the Chinese version of the short version of International Physical Activity Questionnaire (short- Chinese IPAQ).</description>
  </secondary_outcome>
  <enrollment type="Actual">235</enrollment>
  <condition>Coronary Heart Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood testing for the blood glucose, lipid profile&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        CHD high-risk patients (corresponding to the inclusion criteria)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older;&#xD;
&#xD;
          -  Have no CHD at enrollment;&#xD;
&#xD;
          -  At high risk of CHD with at least two of the following risk factors:&#xD;
&#xD;
               -  current smoking: current smokers are defined as individuals who smoked regularly&#xD;
                  during the last 12 months&#xD;
&#xD;
               -  central obesity: for Chinese, central obesity is defined as waist circumstance&#xD;
                  above 90cm for male and 80cm for female, or with BMI above 30kg/m²&#xD;
&#xD;
               -  raised BP (systolic BP [SBP] ≥ 130 mmHg or diastolic BP [DBP] ≥85 mmHg or under&#xD;
                  antihypertensive treatment)&#xD;
&#xD;
               -  raised fasting BG (FBG) (100mg/dL [5.6mmol/L]) or under treatment with insulin or&#xD;
                  oral hypoglycemic agents&#xD;
&#xD;
               -  elevated TG (150mg/dL [1.7mmol/L])&#xD;
&#xD;
               -  elevated TC (≥ 240 mg/dL [5.18 mmol/L])&#xD;
&#xD;
               -  raised LDL-C (≥ 160 mg/dL [4.15 mmol/L])&#xD;
&#xD;
               -  decreased HDL-C (&lt;40 mg/dL [1.03 mmol/L] for males, and &lt;50 mg/dL [1.29 mmol/L]&#xD;
                  for females)&#xD;
&#xD;
               -  undergoing hyperlipidemia treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired bilateral hearing&#xD;
&#xD;
          -  Impaired mental status (according to their medical record)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SekYing CHAIR, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qilu Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinan Central Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Youjuan Zhang</investigator_full_name>
    <investigator_title>Graduate Assistant</investigator_title>
  </responsible_party>
  <keyword>food frequency questionnaire; psychometric properties</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All questionnaires and other collected data will be stored in a locked file cabinet, and no names or other personal data of participants will be used in publication. Only the PI and her supervisor will have access to these data.</ipd_description>
  </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/NCT03292055
org study id: 2016.557
nct id: NCT03292055
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the psychometric properties of a newly developed FFQ specified
      for northern Chinese CHD and their high risk patients (CHD-FFQ). The psychometric properties
      include test-retest reliability, content validity, convergent validity, discriminant
      validity, concurrent validity and predictive validity. Particularly, this study will measure
      the physiological indicators, including plasma lipid profile (i.e. TG, TC, HDL-C, LDL-C), BG,
      BP and BMI twice at baseline and the end. The level of these physiological indicators will be
      compared with the fat intake measured by the CHD-FFQ, i.e. the baseline intake to test its
      convergent validity. It is also expected to predict the diet-related progression of CHD risks
      among high-risk individuals, i.e. patients with two or more CHD risk factors as following:
      raised fasting blood glucose (BG) level, increased blood pressure (BP), increased
      triglycerides (TG), decreased HDL-Cholesterol (HDL-C), increased LDL-Cholesterol (LDL-C),
      smoking and central obesity (International Diabetes Federation, 2015). In addition, this
      study will provide the FFQ's concurrent validity in assessing the intake of energy and
      nutrients against the CDC-FFQ. Moreover, whether the FFQ could detect the known differences
      in energy intake between men and women will be established for its discriminant validity.
observational model: Cohort
time perspective: Prospective
measure: Intake of Food
time frame: January-February, April- May, July- August, October- November
description: The newly developed FFQ (CHD-FFQ) will be applied to the participants to collect their dietary intake of food.
measure: Cardiac-related physiological blood parameters
time frame: January- February, October- November
description: In the beginning and the end of the study, the medical records of the participants will be refered to get the blood glucose, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in the past three months, in the department and the community centers.
measure: Height
time frame: January-February, April- May, July- August, October- November
description: Participant's height will be measured to the nearest 0.5 cm, with a right-angle triangle resting on the scalp and against the wall, having the back square against the wall tape and eyes looking straight ahead. The height will be measured without wearing shoes.
measure: Weight
time frame: January-February, April- May, July- August, October- November
description: A calibrated scale with the resolution of 0.1 kg will be used to measure the weight of the participants, who will be asked to wear light clothes during measurement. The weight will be measured without shoes.
measure: BMI
time frame: January-February, April- May, July- August, October- November
description: weight and height will be combined to report BMI in kg/m^2
measure: Waist circumstance
time frame: January-February, April- May, July- August, October- November
description: Waist circumstance will be taken at the midpoint between the top of the iliac crest and the lower margin of the palpable rib
measure: Blood pressure
time frame: January-February, April- May, July- August, October- November
description: To take the blood pressure, the participant will be asked to be seated for at least 15 minutes with his/her legs uncrossed (WHO, 2008). Two BP measurements will be taken and between the two readings, the participant will have three minutes' rest.
measure: Intake of Food
time frame: October-November
description: As a criterion, the FFQ developed by Chinese CDC will be applied to the participants to collect their dietary intake of food.
measure: Sociodemographic information
time frame: January-February
description: Age, gender, marital status, occupation, educational level, living conditions, financial background, and living areas will be collected using a self-developed questionnaire.
measure: General clinical information
time frame: January-February
description: Smoking history, family history and clinical data will be collected using a self-developed questionnaire.
measure: Clinical Information
time frame: October- November
description: Their clinical information on hospital readmission, surgery or medical procedures, and medication adjustment during the last year will be collected.
measure: Physical activity level
time frame: January-February, April- May, July- August, October- November
description: The physical activity level of the participants will be measured using the Chinese version of the short version of International Physical Activity Questionnaire (short- Chinese IPAQ).
Blood testing for the blood glucose, lipid profile
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SekYing CHAIR, PHD
role: Study Director
affiliation: Chinese University of Hong Kong
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Youjuan Zhang
investigator title: Graduate Assistant
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: No
ipd description: All questionnaires and other collected data will be stored in a locked file cabinet, and no names or other personal data of participants will be used in publication. Only the PI and her supervisor will have access to these data.