<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/NCT04497064</url>
  </required_header>
  <id_info>
    <org_study_id>19-E-364</org_study_id>
    <nct_id>NCT04497064</nct_id>
  </id_info>
  <brief_title>Breakfast Knowledge, Beliefs, and Habits of Exercising Adults</brief_title>
  <official_title>Breakfast Knowledge, Beliefs, and Habits of Exercising Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio University</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>
      This study is being done to determine typical breakfast consumption habits in various&#xD;
      populations of exercisers. Participants will be asked a series of questions pertaining to&#xD;
      their participation in regular exercise, their current breakfast consumption, food&#xD;
      preferences, meal timing, and general knowledge of sports nutrition and pre-exercise&#xD;
      breakfast consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will complete a one-time survey regarding breakfast habits and beliefs and&#xD;
      sports nutrition knowledge, as well as the type, frequency, and intensity of exercise engaged&#xD;
      in on a weekly basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2020</start_date>
  <completion_date type="Actual">March 24, 2020</completion_date>
  <primary_completion_date type="Actual">March 24, 2020</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>breakfast composition</measure>
    <time_frame>Day 1</time_frame>
    <description>Questions asked include typical composition of breakfast, such as Meat, Plant-based protein (beans, lentils, peas), Nuts or seeds, Cheese, Eggs, Yogurt or dairy, Bread, Starchy vegetables, Non-starchy vegetables, Grains, Fruit/fruit juice, or Protein/meal replacement bars</description>
  </primary_outcome>
  <primary_outcome>
    <measure>breakfast habits</measure>
    <time_frame>Day 1</time_frame>
    <description>questions regarding typical breakfast consumption habits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>breakfast beliefs</measure>
    <time_frame>Day 1</time_frame>
    <description>questions regarding how individuals felt about eating breakfast</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sports nutrition knowledge</measure>
    <time_frame>Day 1</time_frame>
    <description>questions from the 49-SNKI to assess sports nutrition knowledge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>exercise habits</measure>
    <time_frame>Day 1</time_frame>
    <description>questions on frequency, duration and intensity of typical exercise sessions</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">585</enrollment>
  <condition>Nutrition</condition>
  <arm_group>
    <arm_group_label>Athlete</arm_group_label>
    <description>those who identified as participating in athletic competitions at DI, intramural, club or competitive levels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-athletes</arm_group_label>
    <description>those who did not identify as participating in athletic competitions at DI, intramural, club or competitive levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey</intervention_name>
    <description>survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits</description>
    <arm_group_label>Athlete</arm_group_label>
    <arm_group_label>non-athletes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        anyone with a valid Ohio University email address or who saw the advertisement on social&#xD;
        media who was older than 18 and participates in structured exercise&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years old&#xD;
&#xD;
          -  regular exerciser&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years old&#xD;
&#xD;
          -  do not regularly exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Ohio University Exercise Physiology Lab</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio University</investigator_affiliation>
    <investigator_full_name>Angela Hillman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>upon request</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/NCT04497064
org study id: 19-E-364
nct id: NCT04497064
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being done to determine typical breakfast consumption habits in various
      populations of exercisers. Participants will be asked a series of questions pertaining to
      their participation in regular exercise, their current breakfast consumption, food
      preferences, meal timing, and general knowledge of sports nutrition and pre-exercise
      breakfast consumption.
Participants will complete a one-time survey regarding breakfast habits and beliefs and
      sports nutrition knowledge, as well as the type, frequency, and intensity of exercise engaged
      in on a weekly basis.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: breakfast composition
time frame: Day 1
description: Questions asked include typical composition of breakfast, such as Meat, Plant-based protein (beans, lentils, peas), Nuts or seeds, Cheese, Eggs, Yogurt or dairy, Bread, Starchy vegetables, Non-starchy vegetables, Grains, Fruit/fruit juice, or Protein/meal replacement bars
measure: breakfast habits
time frame: Day 1
description: questions regarding typical breakfast consumption habits
measure: breakfast beliefs
time frame: Day 1
description: questions regarding how individuals felt about eating breakfast
measure: sports nutrition knowledge
time frame: Day 1
description: questions from the 49-SNKI to assess sports nutrition knowledge
measure: exercise habits
time frame: Day 1
description: questions on frequency, duration and intensity of typical exercise sessions
arm group label: Athlete
description: those who identified as participating in athletic competitions at DI, intramural, club or competitive levels
arm group label: non-athletes
description: those who did not identify as participating in athletic competitions at DI, intramural, club or competitive levels
intervention type: Other
intervention name: survey
description: survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits
arm group label: Athlete
arm group label: non-athletes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: Angela Hillman
investigator title: Assistant Professor
sharing ipd: No
ipd description: upon request