<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/NCT03268577</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2017-01184</org_study_id>
    <secondary_id>NCI-2017-01184</secondary_id>
    <secondary_id>11CN155</secondary_id>
    <secondary_id>DCP-003</secondary_id>
    <nct_id>NCT03268577</nct_id>
  </id_info>
  <brief_title>Internet-Based and Self-Reports in Assessing Diet and Physical Activity Within AARP</brief_title>
  <official_title>Interactive Diet and Activity Tracking in AARP (IDATA): Biomarker Based Validation Study of Internet-Based and Conventional Self-Report Instruments for Assessing Diet and Physical Activity Within AARP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research trial studies how well internet-based and self-report instruments measure food&#xD;
      intake and physical activity levels and their relationship with disease within American&#xD;
      Association of Retired Persons (AARP) members. Comparing new internet-based questionnaires&#xD;
      developed by the National Cancer Institute that report all the foods consumed and activities&#xD;
      performed in an entire day to standardized physical measurements may help to determine if the&#xD;
      information collected is accurate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate the measurement error structure of self-reported dietary assessment instruments,&#xD;
      including, a food frequency questionnaire (National Cancer Institute [NCI]'s Diet History&#xD;
      Questionnaire-II [DHQ-II]), and 24-hour recalls using the new automated self-administered&#xD;
      24-hour dietary recall (ASA24) instrument with respect to absolute energy intake, absolute&#xD;
      protein intake, and protein density-and potentially other nutritional factors such as&#xD;
      potassium intake.&#xD;
&#xD;
      II. Investigate the measurement error structure associated with self-reported active and&#xD;
      sedentary behaviors, including multiple administrations of a new 24-hour recall (activity&#xD;
      completed over time in 24-hours [ACT24]) and selected questionnaires using energy expenditure&#xD;
      from doubly labeled water (DLW) and physical activities measures of physical activity&#xD;
      monitors as reference instruments.&#xD;
&#xD;
      III. Evaluate alternative analytic approaches for combining different types of self-report&#xD;
      data on diet and physical activity-related behaviors as well as self-report plus objective&#xD;
      data (derived from activity monitors, heart rate monitors e.g.).&#xD;
&#xD;
      IV. Within the context of an AARP-based cohort, explore the adjustment of observed RRs for&#xD;
      several key cancer hypotheses related to diet and physical activity based on the measurement&#xD;
      error data provided by the new study.&#xD;
&#xD;
      V. Evaluate the potential for 'energy adjustment' that incorporates physical activity and&#xD;
      body size.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients complete the ASA24 about foods, cooking methods, and other aspects of diet every 2&#xD;
      months for up to 6 times, and complete ACT24 about activities and time reporting every 2&#xD;
      months for up to 6 times. Patients also complete DHQ-II questionnaires at the beginning and&#xD;
      end of the study about the frequency and portion sizes of foods consumed over the past 12&#xD;
      months, provide a 7-day food checklist twice with the DHQ-II, and provide a 4-day food record&#xD;
      twice, once every 6 months. Physical activity monitors are worn to measure movement at&#xD;
      different intensity levels and sitting or standing periods, twice during the study with 6&#xD;
      months between each time they are worn.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">December 31, 2013</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>Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be evaluated against energy intake measured by doubly labeled water (DLW). Dietary intake of protein, potassium, and other nutrients will be compared to urinary nitrogen (UN), urinary potassium, and other nutrients measured in urine and blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement error structure of self-reported active and sedentary behaviors (e.g. activity completed over time in 24-hours [ACT24], questionnaires)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined using energy expenditure measured by DLW, physical activity monitor data, and hear rate monitor data. Data will be also used to evaluate alternative statistical methods for combining different types of self-report data on diet and physical activity-related behaviors as well as self-report plus objectively measured data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour urine samples</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be analyzed for UN, potassium, para-amino benzoic acid (PABA), and other nutrients that are potential objective markers of intakes. First morning void urine also will be evaluated for its potential to be used as a source of biomarkers replacing 24-hr urine. Urine will be analyzed to characterize metabolic profiles of individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood sample analyses</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be processed to extract plasma and red and white blood cells, and analyzed in the future for vitamin C, folate, vitamin E, vitamin A, carotenoids, lipids, fatty acids and other nutrients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva samples</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement error structure of self-reported dietary assessment instruments</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Evaluated using latent-variable (measurement error) models. The models allow self-reported dietary intake to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models allow one to estimate the joint distribution of true and reported intake, and to estimate parameters of interest such as the correlation of true and reported intake and the &quot;attenuation factor&quot;, or slope in the regression of true intake on reported intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement error in self-reported total physical activity (measured in energy expenditure)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Evaluated using latent-variable (measurement error) models. The models allow total energy expenditure derived from a physical activity monitor to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models to help develop better algorithms for estimating total energy expenditure from the measurements of physical activity monitors. For other physical activity measures of interest, such as minutes of vigorous activity or minutes of sedentary time per day, will use the physical activity monitors to derive approximately unbiased estimates that can be used as reference instruments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in measurement error</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will use multivariate measurement error models to estimate the joint distribution of true and reported values (nutrient intake, total energy, physical activity, body size). Then calculate residual reported intake (given reported total energy, physical activity and body size) and residual true intake (given true total energy, physical activity and body size), and assess the measurement error properties of reported residual intake as a measure of true residual intake. Specifically, will calculate the correlation of true and reported residual intake and the attenuation factor for residual reported intake and compare them to the same measures calculated for the simpler model that adjusts only for energy.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1130</enrollment>
  <condition>Healthy Subject</condition>
  <arm_group>
    <arm_group_label>Prevention (diet and activity tracking)</arm_group_label>
    <description>Patients complete the ASA24 about foods, cooking methods, and other aspects of diet every 2 months for up to 6 times, and complete ACT24 about activities and time reporting every 2 months for up to 6 times. Patients also complete DHQ-II questionnaires at the beginning and end of the study about the frequency and portion sizes of foods consumed over the past 12 months, provide a 7-day food checklist twice with the DHQ-II, and provide a 4-day food record twice, once every 6 months. Physical activity monitors are worn to measure movement at different intensity levels and sitting or standing periods, twice during the study with 6 months between each time they are worn.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Complete ASA24</description>
    <arm_group_label>Prevention (diet and activity tracking)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Complete ACT24 reporting</description>
    <arm_group_label>Prevention (diet and activity tracking)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring Device</intervention_name>
    <description>Wear accelerometer and inclinometer physical activity monitors</description>
    <arm_group_label>Prevention (diet and activity tracking)</arm_group_label>
    <other_name>Monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Prevention (diet and activity tracking)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva, urine, blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Members within the existing NIH-AARP Diet and Health Study members (aged 50-71 in 1995-96)&#xD;
        and younger AARP members born after 1945 ('baby boomers') and living in the Pittsburgh area&#xD;
        in Pennsylvania&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking or reading&#xD;
&#xD;
          -  Weight loss diet (liquid or medications)&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Body mass index &lt; 18.5 or &gt;= 40 (kg/m^2)&#xD;
&#xD;
          -  History of renal failure, congestive heart failure, or other conditions involving&#xD;
             disturbances in fluid balance&#xD;
&#xD;
          -  Limited mobility&#xD;
&#xD;
          -  Use of supplemental oxygen&#xD;
&#xD;
          -  Allergy to para-amino benzoic acid (PABA)&#xD;
&#xD;
          -  No access to high-speed internet&#xD;
&#xD;
          -  No more than one AARP member in the household can participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>heather bowles</last_name>
    <role>Principal Investigator</role>
    <affiliation>NCI Division of Cancer Control and Population Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NCI Division of Cancer Control and Population Sciences</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03268577
org study id: NCI-2017-01184
secondary id: NCI-2017-01184
secondary id: 11CN155
secondary id: DCP-003
nct id: NCT03268577
lead sponsor: 
has dmc: No
This research trial studies how well internet-based and self-report instruments measure food
      intake and physical activity levels and their relationship with disease within American
      Association of Retired Persons (AARP) members. Comparing new internet-based questionnaires
      developed by the National Cancer Institute that report all the foods consumed and activities
      performed in an entire day to standardized physical measurements may help to determine if the
      information collected is accurate.
PRIMARY OBJECTIVES:

      I. Evaluate the measurement error structure of self-reported dietary assessment instruments,
      including, a food frequency questionnaire (National Cancer Institute [NCI]'s Diet History
      Questionnaire-II [DHQ-II]), and 24-hour recalls using the new automated self-administered
      24-hour dietary recall (ASA24) instrument with respect to absolute energy intake, absolute
      protein intake, and protein density-and potentially other nutritional factors such as
      potassium intake.

      II. Investigate the measurement error structure associated with self-reported active and
      sedentary behaviors, including multiple administrations of a new 24-hour recall (activity
      completed over time in 24-hours [ACT24]) and selected questionnaires using energy expenditure
      from doubly labeled water (DLW) and physical activities measures of physical activity
      monitors as reference instruments.

      III. Evaluate alternative analytic approaches for combining different types of self-report
      data on diet and physical activity-related behaviors as well as self-report plus objective
      data (derived from activity monitors, heart rate monitors e.g.).

      IV. Within the context of an AARP-based cohort, explore the adjustment of observed RRs for
      several key cancer hypotheses related to diet and physical activity based on the measurement
      error data provided by the new study.

      V. Evaluate the potential for 'energy adjustment' that incorporates physical activity and
      body size.

      OUTLINE:

      Patients complete the ASA24 about foods, cooking methods, and other aspects of diet every 2
      months for up to 6 times, and complete ACT24 about activities and time reporting every 2
      months for up to 6 times. Patients also complete DHQ-II questionnaires at the beginning and
      end of the study about the frequency and portion sizes of foods consumed over the past 12
      months, provide a 7-day food checklist twice with the DHQ-II, and provide a 4-day food record
      twice, once every 6 months. Physical activity monitors are worn to measure movement at
      different intensity levels and sitting or standing periods, twice during the study with 6
      months between each time they are worn.
observational model: Cohort
time perspective: Prospective
measure: Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record
time frame: Up to 12 months
description: Will be evaluated against energy intake measured by doubly labeled water (DLW). Dietary intake of protein, potassium, and other nutrients will be compared to urinary nitrogen (UN), urinary potassium, and other nutrients measured in urine and blood.
measure: Measurement error structure of self-reported active and sedentary behaviors (e.g. activity completed over time in 24-hours [ACT24], questionnaires)
time frame: Up to 12 months
description: Will be examined using energy expenditure measured by DLW, physical activity monitor data, and hear rate monitor data. Data will be also used to evaluate alternative statistical methods for combining different types of self-report data on diet and physical activity-related behaviors as well as self-report plus objectively measured data.
measure: 24-hour urine samples
time frame: Up to 12 months
description: Will be analyzed for UN, potassium, para-amino benzoic acid (PABA), and other nutrients that are potential objective markers of intakes. First morning void urine also will be evaluated for its potential to be used as a source of biomarkers replacing 24-hr urine. Urine will be analyzed to characterize metabolic profiles of individuals.
measure: Fasting blood sample analyses
time frame: Up to 12 months
description: Will be processed to extract plasma and red and white blood cells, and analyzed in the future for vitamin C, folate, vitamin E, vitamin A, carotenoids, lipids, fatty acids and other nutrients.
measure: Saliva samples
time frame: Up to 12 months
description: Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.
measure: Measurement error structure of self-reported dietary assessment instruments
time frame: Up to 12 months
description: Evaluated using latent-variable (measurement error) models. The models allow self-reported dietary intake to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models allow one to estimate the joint distribution of true and reported intake, and to estimate parameters of interest such as the correlation of true and reported intake and the "attenuation factor", or slope in the regression of true intake on reported intake.
measure: Measurement error in self-reported total physical activity (measured in energy expenditure)
time frame: Up to 12 months
description: Evaluated using latent-variable (measurement error) models. The models allow total energy expenditure derived from a physical activity monitor to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models to help develop better algorithms for estimating total energy expenditure from the measurements of physical activity monitors. For other physical activity measures of interest, such as minutes of vigorous activity or minutes of sedentary time per day, will use the physical activity monitors to derive approximately unbiased estimates that can be used as reference instruments.
measure: Reduction in measurement error
time frame: Up to 12 months
description: Will use multivariate measurement error models to estimate the joint distribution of true and reported values (nutrient intake, total energy, physical activity, body size). Then calculate residual reported intake (given reported total energy, physical activity and body size) and residual true intake (given true total energy, physical activity and body size), and assess the measurement error properties of reported residual intake as a measure of true residual intake. Specifically, will calculate the correlation of true and reported residual intake and the attenuation factor for residual reported intake and compare them to the same measures calculated for the simpler model that adjusts only for energy.
arm group label: Prevention (diet and activity tracking)
description: Patients complete the ASA24 about foods, cooking methods, and other aspects of diet every 2 months for up to 6 times, and complete ACT24 about activities and time reporting every 2 months for up to 6 times. Patients also complete DHQ-II questionnaires at the beginning and end of the study about the frequency and portion sizes of foods consumed over the past 12 months, provide a 7-day food checklist twice with the DHQ-II, and provide a 4-day food record twice, once every 6 months. Physical activity monitors are worn to measure movement at different intensity levels and sitting or standing periods, twice during the study with 6 months between each time they are worn.
intervention type: Other
intervention name: Internet-Based Intervention
description: Complete ASA24
arm group label: Prevention (diet and activity tracking)
intervention type: Other
intervention name: Internet-Based Intervention
description: Complete ACT24 reporting
arm group label: Prevention (diet and activity tracking)
intervention type: Device
intervention name: Monitoring Device
description: Wear accelerometer and inclinometer physical activity monitors
arm group label: Prevention (diet and activity tracking)
other name: Monitor
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Prevention (diet and activity tracking)
saliva, urine, blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: heather bowles
role: Principal Investigator
affiliation: NCI Division of Cancer Control and Population Sciences
facility: 
country: United States
responsible party type: Sponsor