<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/NCT04468672</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS8559</org_study_id>
    <nct_id>NCT04468672</nct_id>
  </id_info>
  <brief_title>Eating Behaviors in Shift Workers</brief_title>
  <official_title>The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia 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>
      This study will compare eating behaviors and measures of hunger and fullness between day and&#xD;
      night workers in order to better understand why night workers are at increased risk for&#xD;
      obesity and related diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Statistician will be blinded to participant group and condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Food intake</measure>
    <time_frame>24-hours intake period</time_frame>
    <description>Food by weight (g) in response to variations in portion served</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy intake</measure>
    <time_frame>24-hours intake period</time_frame>
    <description>Food by energy (kcal) in response to variations in portion served</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy density consumed</measure>
    <time_frame>24-hours intake period</time_frame>
    <description>Energy density consumed (kcal/g) in response to variations in portion served</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetite-regulating hormones</measure>
    <time_frame>2-hours measurement period</time_frame>
    <description>Appetite-regulating hormones, including Glucagon-like-peptide 1 (GLP-1) and ghrelin will be analyzed from plasma from whole blood samples collected while fasted and at 30, 60, 90, and 120 min postprandial. Area under the curve of plasma concentrations will be calculated for each individual appetite-regulating hormone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger and fullness</measure>
    <time_frame>24-hours measurement period</time_frame>
    <description>Subjective measures related to hunger, fullness, and prospective consumption will be measured before and after meals via visual analog scales. The range of scores are 0 mm to 100 mm, with higher scores indicating greater feelings of the corresponding measure (e.g. greater hunger). Post-meal measures, adjusted for the corresponding pre-meal measure, will be analyzed as individual outcomes. Area under the curve will also be calculated for each measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Shift Work Type Circadian Rhythm Sleep Disorder</condition>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Day worker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men and women who work only day shift for at least 3 consecutive days of the week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Night worker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men and women who work only night shift for at least 3 consecutive days of the week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Portion size</intervention_name>
    <description>The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.</description>
    <arm_group_label>Day worker</arm_group_label>
    <arm_group_label>Night worker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Work ~ 8-hour shifts during day or night on 3 or more consecutive days of the week&#xD;
&#xD;
          -  BMI 19-35 kg/m^2&#xD;
&#xD;
          -  Age 20-55 years of age&#xD;
&#xD;
          -  Metabolically healthy&#xD;
&#xD;
          -  Weight stable over previous 3 months&#xD;
&#xD;
          -  Lives in New York City area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or less than 1 year postpartum at time of study&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
&#xD;
          -  Rotating shift work&#xD;
&#xD;
          -  Habitual sleep duration of more than 6 hour per night&#xD;
&#xD;
          -  Obstructive sleep apnea&#xD;
&#xD;
          -  Transmeridian travel&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Participation in diet or weight loss program in the 3 months prior to enrollment&#xD;
&#xD;
          -  Psychiatric or sleep disorder&#xD;
&#xD;
          -  Food allergies or intolerances&#xD;
&#xD;
          -  Dislike of or unwillingness to eat test foods&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faris M Zuraikat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie-Pierre St-Onge, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mehreen Bhatti, BS</last_name>
    <phone>917-397-6451</phone>
    <email>mzb2107@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samantha Scaccia, MS</last_name>
    <email>ses2272@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehreen Bhatti</last_name>
      <phone>917-397-6451</phone>
      <email>mzb2107@cumc.columbia.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Marie-Pierre St-Onge</investigator_full_name>
    <investigator_title>Associate Professor of Nutritional Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) will be shared with other researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After the study is completed (data collection, analysis, publication) and after any subsequent funding applications have been submitted.</ipd_time_frame>
    <ipd_access_criteria>Upon request</ipd_access_criteria>
  </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/NCT04468672
org study id: AAAS8559
nct id: NCT04468672
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will compare eating behaviors and measures of hunger and fullness between day and
      night workers in order to better understand why night workers are at increased risk for
      obesity and related diseases.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Statistician will be blinded to participant group and condition.
measure: Food intake
time frame: 24-hours intake period
description: Food by weight (g) in response to variations in portion served
measure: Energy intake
time frame: 24-hours intake period
description: Food by energy (kcal) in response to variations in portion served
measure: Energy density consumed
time frame: 24-hours intake period
description: Energy density consumed (kcal/g) in response to variations in portion served
measure: Appetite-regulating hormones
time frame: 2-hours measurement period
description: Appetite-regulating hormones, including Glucagon-like-peptide 1 (GLP-1) and ghrelin will be analyzed from plasma from whole blood samples collected while fasted and at 30, 60, 90, and 120 min postprandial. Area under the curve of plasma concentrations will be calculated for each individual appetite-regulating hormone
measure: Hunger and fullness
time frame: 24-hours measurement period
description: Subjective measures related to hunger, fullness, and prospective consumption will be measured before and after meals via visual analog scales. The range of scores are 0 mm to 100 mm, with higher scores indicating greater feelings of the corresponding measure (e.g. greater hunger). Post-meal measures, adjusted for the corresponding pre-meal measure, will be analyzed as individual outcomes. Area under the curve will also be calculated for each measure.
arm group label: Day worker
arm group type: Active Comparator
description: Men and women who work only day shift for at least 3 consecutive days of the week
arm group label: Night worker
arm group type: Active Comparator
description: Men and women who work only night shift for at least 3 consecutive days of the week
intervention type: Behavioral
intervention name: Portion size
description: The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.
arm group label: Day worker
arm group label: Night worker
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Faris M Zuraikat, PhD
role: Principal Investigator
affiliation: Columbia University
last name: Marie-Pierre St-Onge, PhD
role: Principal Investigator
affiliation: Columbia University
last name: Mehreen Bhatti, BS
phone: 917-397-6451
email: mzb2107@cumc.columbia.edu
last name: Samantha Scaccia, MS
email: ses2272@cumc.columbia.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Marie-Pierre St-Onge
investigator title: Associate Professor of Nutritional Medicine
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) will be shared with other researchers upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: After the study is completed (data collection, analysis, publication) and after any subsequent funding applications have been submitted.
ipd access criteria: Upon request