<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/NCT03292380</url>
  </required_header>
  <id_info>
    <org_study_id>ORE File#20262</org_study_id>
    <nct_id>NCT03292380</nct_id>
  </id_info>
  <brief_title>Validation of a 24-hour Caffeine Intake Recall</brief_title>
  <official_title>Evaluation of a 24-hour Caffeine Intake Assessment Compared to Urinary Biomarkers of Caffeine Intake and a Brief Caffeinated Beverage Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Waterloo</source>
  <oversight_info>
    <has_dmc>No</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>
      A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in&#xD;
      the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary&#xD;
      Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods,&#xD;
      beverages and supplements. The objective of this study was to evaluate the accuracy of the&#xD;
      CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage&#xD;
      intake frequency screener (CBQ) among a young adult population.&#xD;
&#xD;
      79 young adults ages 18 to 29 years provided 24-hour urine samples and completed the CIR-24&#xD;
      and CBQ. Excretion rates for caffeine and eight caffeine metabolites were quantified from&#xD;
      urine samples using high performance liquid chromatography-polarity switching electrospray&#xD;
      ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal&#xD;
      standards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine&#xD;
      concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ)&#xD;
      among a young adult population.&#xD;
&#xD;
      A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in&#xD;
      the previous 24 hours. The online, self-administered CIR-24 was developed to measure dietary&#xD;
      intake of caffeine from food, beverages, and supplements. The tool was based on the Automated&#xD;
      Self-Administered 24-hour Dietary Assessment Tool (ASA24), a web-based, self-administered&#xD;
      tool for collecting dietary recalls and records. ASA24 uses a multiple-pass method adapted&#xD;
      from the Automated Multiple-Pass Method (AMPM) used in NHANES in the US and the Canadian&#xD;
      Community Health Survey in Canada. The same general question structure was used in this&#xD;
      custom online survey, but the items queried were limited to foods, beverages and supplements&#xD;
      that may contain caffeine. The tool was created for the Canadian context by listing only&#xD;
      Canadian products, changing container sizes to reflect the Canadian marketplace, and&#xD;
      including a French version. The food, beverage, and supplement categories and sub-categories&#xD;
      can be found in Supplemental Table 1. Specific items listed were based on ASA24 and the&#xD;
      Canadian Nutrient File, with additional items identified through the USDA National Nutrient&#xD;
      Databases and internet searches. Respondents were asked about the consumption of items from&#xD;
      each of four main categories (beverages, foods, energy products with added caffeine, and&#xD;
      supplements) in the prior day. Based on each food or beverage reported, the participant&#xD;
      receives tailored probes based on their responses, to identify the specific items that may&#xD;
      have contained caffeine (e.g., if carbonated beverage consumption was reported, the&#xD;
      participant is asked to specify the type of carbonated beverage and brand consumed). Amounts&#xD;
      of each item consumed were ascertained based on the particular category: food amounts were&#xD;
      estimated by the number of items/pieces consumed, or by a volume amount (depending on the&#xD;
      item); beverage amounts were estimated using images of container types and sizes (adapted&#xD;
      from the ASA24) (or volume for powders, liquids, and concentrates); and supplements were&#xD;
      estimated by unit (or volume for powders and liquids). The CIR-24 tool is available at&#xD;
      http://davidhammond.ca/wp-content/uploads/2015/11/2014-CED-Technical-Report.pdf.A database&#xD;
      was compiled of the caffeine content of all food and beverage items in the Canadian Nutrient&#xD;
      File listed as containing caffeine (with some additional items from the USDA National&#xD;
      Nutrient Database for Standard Reference), plus energy drinks, shots, and products (sourced&#xD;
      from the nutrition information on products purchased in previous studies, as well as internet&#xD;
      searches), and supplements listed as containing caffeine in Health Canada's Licensed Natural&#xD;
      Health Products Database&#xD;
      (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php) or&#xD;
      identified through an online pharmacy (www.well.ca). More precise and brand-specific values&#xD;
      were added for popular products such as coffee, using information provided by manufacturers&#xD;
      (e.g., Starbucks, Tim Horton's, McDonald's) and/or websites that aggregate nutrition&#xD;
      information (http://www.cspinet.org/new/cafchart.htm).&#xD;
&#xD;
      A paper version of a caffeinated beverage questionnaire (CBQ) from the Fred Hutchison Cancer&#xD;
      Centre, adapted slightly for use in Canada (e.g., mL measures were included in addition to&#xD;
      fluid ounces), was also administered.The CBQ included 13 beverage categories, including&#xD;
      caffeinated and decaffeinated coffee (brewed and instant) and tea, energy drinks and highly&#xD;
      caffeinated sodas, regular colas and root beer, and caffeine-free colas and root beer. Nine&#xD;
      frequency categories were included: Never or less than once per month; 1-3 per month; 1 per&#xD;
      week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. A&#xD;
      reference for a 'medium' size for each type of beverage category was provided; respondents&#xD;
      stated whether each drink size was small, medium or large in comparison to the reference&#xD;
      amount. Responses to the CBQ were used to calculate average daily caffeine consumption for&#xD;
      each respondent. First, the number of annual servings consumed for each questionnaire item&#xD;
      was calculated by multiplying the reported frequency by the reported portion size. A 'small'&#xD;
      size was multiplied by a serving ratio of 0.5, and a 'large' size was multiplied by 1.5.&#xD;
      Next, the average annual volume of each beverage consumed was divided by 365 to estimate the&#xD;
      daily intake of each beverage. The caffeine database that accompanies the tool was used to&#xD;
      calculate the amount of caffeine consumed in milligrams. In cases in which frequency data for&#xD;
      items were missing, we assumed that none was consumed, and when a frequency was entered but&#xD;
      no portion size was indicated, the 'medium' size was assumed.&#xD;
&#xD;
      For each participant, all urine samples were combined, and the total volume of the entire&#xD;
      24-hour sample was recorded. A sample from each participant was aliquoted into a 2 mL&#xD;
      cryovial, and immediately frozen at -80°C. Samples were moved for 8 days to a -20°C freezer&#xD;
      due to logistical issues, and were later returned to -80°C. At the end of the study period,&#xD;
      all samples were transported in insulated containers with dry ice to the CDC Nutritional&#xD;
      Biomarkers Branch in Atlanta, GA for analysis.&#xD;
&#xD;
      Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites&#xD;
      (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X);&#xD;
      1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U);&#xD;
      1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil&#xD;
      (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching&#xD;
      electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled&#xD;
      internal standards based on a method reported previously.(26) Existing studies indicate that&#xD;
      these metabolites have moderate correlation with caffeine intake (14). The limits of&#xD;
      detection were: 0.05 μmol/L for 1U; 0.01 μmol/L for theophylline; 0.02 μmol/L for 13U and&#xD;
      17U; 0.005 μmol/L 137U; 0.03 μmol/L for 1X; 0.003 mmol/L for caffeine; 0.006 μmol/L for 17X;&#xD;
      and, 0.1 μmol/L for AAMU. Samples that had amounts below the limits of detection were&#xD;
      excluded for that particular metabolite.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2015</start_date>
  <completion_date type="Actual">August 19, 2015</completion_date>
  <primary_completion_date type="Actual">August 19, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour dietary intake from CIR-24</measure>
    <time_frame>The day after the urine collection</time_frame>
    <description>The amount of caffeine consumed in the previous 24 hours using the CIR-24 tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentrations of caffeine and 8 additional metabolites</measure>
    <time_frame>24 hour collection, one day prior to self-report techniques</time_frame>
    <description>Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously. Existing studies indicate that these metabolites have moderate correlation with caffeine intake.&#xD;
Urine samples were collected from the time participants woke the following day, for the subsequent 24-hour period. Participants were instructed to discard the first void of the 24-hour period, but to include the final void at the end of the 24-hour period (i.e., the next morning).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily caffeine intake according to CBQ</measure>
    <time_frame>The previous 30 days</time_frame>
    <description>The average amount of caffeine consumed over one day using the CBQ</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Caffeine-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Caffeine intake recall</arm_group_label>
    <description>All subjects completed 24-hour urine collection, and subsequently completed the 24-hour Caffeine Intake Recall (CIR-24) developed by the research group and the Caffeinated Beverage Frequency Questionnaire (CBQ) developed by the Fred Hutchison Cancer Centre. The order of completing the CIR-24 and the CBQ was alternated each day of data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention was included</intervention_name>
    <arm_group_label>Caffeine intake recall</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 85 young adults were recruited from a university community in southwestern&#xD;
        Ontario from June to August, 2015. Recruitment strategies included distributing flyers to&#xD;
        individuals on campus and in community settings, posting flyers in public areas, and making&#xD;
        announcements to undergraduate classes using a consecutive sampling technique. We attempted&#xD;
        to recruit an equal amount of individuals who self-reported consuming low, moderate, and&#xD;
        high amounts of caffeinated beverages (within each sex); however, the caffeine consumption&#xD;
        quotas were relaxed due to low response from high-intake consumers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  17-30 years of age&#xD;
&#xD;
          -  read and speak English&#xD;
&#xD;
          -  consumed at least some caffeine in a typical day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had smoked a cigarette in the past month&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  taking oral contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We attempted to recruit an equal number of males and females, according to self-identified gender.</gender_description>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David Hammond, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Public Health, University of Waterloo</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Waterloo</investigator_affiliation>
    <investigator_full_name>David Hammond</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Caffeine</keyword>
  <keyword>Dietary intake</keyword>
  <keyword>Validation</keyword>
  <keyword>Dietary methods</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03292380
org study id: ORE File#20262
nct id: NCT03292380
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in
      the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary
      Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods,
      beverages and supplements. The objective of this study was to evaluate the accuracy of the
      CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage
      intake frequency screener (CBQ) among a young adult population.

      79 young adults ages 18 to 29 years provided 24-hour urine samples and completed the CIR-24
      and CBQ. Excretion rates for caffeine and eight caffeine metabolites were quantified from
      urine samples using high performance liquid chromatography-polarity switching electrospray
      ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal
      standards.
The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine
      concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ)
      among a young adult population.

      A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in
      the previous 24 hours. The online, self-administered CIR-24 was developed to measure dietary
      intake of caffeine from food, beverages, and supplements. The tool was based on the Automated
      Self-Administered 24-hour Dietary Assessment Tool (ASA24), a web-based, self-administered
      tool for collecting dietary recalls and records. ASA24 uses a multiple-pass method adapted
      from the Automated Multiple-Pass Method (AMPM) used in NHANES in the US and the Canadian
      Community Health Survey in Canada. The same general question structure was used in this
      custom online survey, but the items queried were limited to foods, beverages and supplements
      that may contain caffeine. The tool was created for the Canadian context by listing only
      Canadian products, changing container sizes to reflect the Canadian marketplace, and
      including a French version. The food, beverage, and supplement categories and sub-categories
      can be found in Supplemental Table 1. Specific items listed were based on ASA24 and the
      Canadian Nutrient File, with additional items identified through the USDA National Nutrient
      Databases and internet searches. Respondents were asked about the consumption of items from
      each of four main categories (beverages, foods, energy products with added caffeine, and
      supplements) in the prior day. Based on each food or beverage reported, the participant
      receives tailored probes based on their responses, to identify the specific items that may
      have contained caffeine (e.g., if carbonated beverage consumption was reported, the
      participant is asked to specify the type of carbonated beverage and brand consumed). Amounts
      of each item consumed were ascertained based on the particular category: food amounts were
      estimated by the number of items/pieces consumed, or by a volume amount (depending on the
      item); beverage amounts were estimated using images of container types and sizes (adapted
      from the ASA24) (or volume for powders, liquids, and concentrates); and supplements were
      estimated by unit (or volume for powders and liquids). The CIR-24 tool is available at
      http://davidhammond.ca/wp-content/uploads/2015/11/2014-CED-Technical-Report.pdf.A database
      was compiled of the caffeine content of all food and beverage items in the Canadian Nutrient
      File listed as containing caffeine (with some additional items from the USDA National
      Nutrient Database for Standard Reference), plus energy drinks, shots, and products (sourced
      from the nutrition information on products purchased in previous studies, as well as internet
      searches), and supplements listed as containing caffeine in Health Canada's Licensed Natural
      Health Products Database
      (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php) or
      identified through an online pharmacy (www.well.ca). More precise and brand-specific values
      were added for popular products such as coffee, using information provided by manufacturers
      (e.g., Starbucks, Tim Horton's, McDonald's) and/or websites that aggregate nutrition
      information (http://www.cspinet.org/new/cafchart.htm).

      A paper version of a caffeinated beverage questionnaire (CBQ) from the Fred Hutchison Cancer
      Centre, adapted slightly for use in Canada (e.g., mL measures were included in addition to
      fluid ounces), was also administered.The CBQ included 13 beverage categories, including
      caffeinated and decaffeinated coffee (brewed and instant) and tea, energy drinks and highly
      caffeinated sodas, regular colas and root beer, and caffeine-free colas and root beer. Nine
      frequency categories were included: Never or less than once per month; 1-3 per month; 1 per
      week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. A
      reference for a 'medium' size for each type of beverage category was provided; respondents
      stated whether each drink size was small, medium or large in comparison to the reference
      amount. Responses to the CBQ were used to calculate average daily caffeine consumption for
      each respondent. First, the number of annual servings consumed for each questionnaire item
      was calculated by multiplying the reported frequency by the reported portion size. A 'small'
      size was multiplied by a serving ratio of 0.5, and a 'large' size was multiplied by 1.5.
      Next, the average annual volume of each beverage consumed was divided by 365 to estimate the
      daily intake of each beverage. The caffeine database that accompanies the tool was used to
      calculate the amount of caffeine consumed in milligrams. In cases in which frequency data for
      items were missing, we assumed that none was consumed, and when a frequency was entered but
      no portion size was indicated, the 'medium' size was assumed.

      For each participant, all urine samples were combined, and the total volume of the entire
      24-hour sample was recorded. A sample from each participant was aliquoted into a 2 mL
      cryovial, and immediately frozen at -80°C. Samples were moved for 8 days to a -20°C freezer
      due to logistical issues, and were later returned to -80°C. At the end of the study period,
      all samples were transported in insulated containers with dry ice to the CDC Nutritional
      Biomarkers Branch in Atlanta, GA for analysis.

      Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites
      (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X);
      1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U);
      1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil
      (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching
      electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled
      internal standards based on a method reported previously.(26) Existing studies indicate that
      these metabolites have moderate correlation with caffeine intake (14). The limits of
      detection were: 0.05 μmol/L for 1U; 0.01 μmol/L for theophylline; 0.02 μmol/L for 13U and
      17U; 0.005 μmol/L 137U; 0.03 μmol/L for 1X; 0.003 mmol/L for caffeine; 0.006 μmol/L for 17X;
      and, 0.1 μmol/L for AAMU. Samples that had amounts below the limits of detection were
      excluded for that particular metabolite.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: 24 hour dietary intake from CIR-24
time frame: The day after the urine collection
description: The amount of caffeine consumed in the previous 24 hours using the CIR-24 tool.
measure: Urine concentrations of caffeine and 8 additional metabolites
time frame: 24 hour collection, one day prior to self-report techniques
description: Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously. Existing studies indicate that these metabolites have moderate correlation with caffeine intake.
Urine samples were collected from the time participants woke the following day, for the subsequent 24-hour period. Participants were instructed to discard the first void of the 24-hour period, but to include the final void at the end of the 24-hour period (i.e., the next morning).
measure: Daily caffeine intake according to CBQ
time frame: The previous 30 days
description: The average amount of caffeine consumed over one day using the CBQ
arm group label: Caffeine intake recall
description: All subjects completed 24-hour urine collection, and subsequently completed the 24-hour Caffeine Intake Recall (CIR-24) developed by the research group and the Caffeinated Beverage Frequency Questionnaire (CBQ) developed by the Fred Hutchison Cancer Centre. The order of completing the CIR-24 and the CBQ was alternated each day of data collection.
intervention type: Other
intervention name: No intervention was included
arm group label: Caffeine intake recall
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: We attempted to recruit an equal number of males and females, according to self-identified gender.
minimum age: 17 Years
maximum age: 30 Years
last name: David Hammond, PhD
role: Principal Investigator
affiliation: University of Waterloo
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Waterloo
investigator full name: David Hammond
investigator title: Professor
sharing ipd: No