<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/NCT04414644</url>
  </required_header>
  <id_info>
    <org_study_id>820064</org_study_id>
    <secondary_id>R21DK100787</secondary_id>
    <nct_id>NCT04414644</nct_id>
  </id_info>
  <brief_title>Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism</brief_title>
  <official_title>Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if, controlling for eating and sleep timing,&#xD;
      caloric intake, and exercise, daytime vs. delayed eating affects body mass, adiposity, and&#xD;
      energy metabolism in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of 4 phases - screening &amp; baseline assessment, eating condition 1,&#xD;
      wash-out period, and eating condition 2. Before and after each phase participants will&#xD;
      complete a 28-hour inpatient assessment at the Clinical and Translational Research Center&#xD;
      (CTRC) of the Hospital of the University of Pennsylvania to study the impact of one's eating&#xD;
      on body weight and fat content, metabolism, and certain markers of metabolism in the blood.&#xD;
&#xD;
      Screening In order to participate in this study the participants must undergo a complete&#xD;
      physical examination and tests of blood and urine. These tests will determine if participants&#xD;
      have any conditions that would prevent them from participating in the study, including&#xD;
      diabetes or any serious uncontrolled medical condition that may interfere with their&#xD;
      participation in the study. Other conditions that would prevent them from taking part are&#xD;
      pregnancy or nursing, a sleep disorder, the use of certain medications, or night-shift work.&#xD;
      A urine pregnancy test will be given to women at this screening visit.&#xD;
&#xD;
      Participants will also complete several surveys of a psychological nature and participate in&#xD;
      a clinical interview. Sleep and exercise schedules are important and will be reviewed during&#xD;
      their visits to see if they match with the study requirements. During the 10 days of the&#xD;
      screening assessment, participants will keep a log in which they will record all food and&#xD;
      beverages that they consume. They will also use these logs to record when they sleep and&#xD;
      exercise. Their activity will be measured by a small electronic wrist activity recorder,&#xD;
      called an Actigraph (about the size of a wrist watch), during this time. This recorder,&#xD;
      similar to a pedometer, records all activity from the arm, and is very useful in determining&#xD;
      if and when they get up at night. Study staff will explain how to keep this information&#xD;
      during the baseline visit. They will return the activity recorder and log to Dr. Allison for&#xD;
      analysis at the end of the 10-days. They are expected to return all study materials,&#xD;
      including the Actigraph, log, and questionnaires.&#xD;
&#xD;
      Assessments Following successful completion of the screening period, they will complete the&#xD;
      first of four assessment visits. This visit will include 28 hours (overnight) spent at the&#xD;
      CTRC, where their meals and snacks will be provided.&#xD;
&#xD;
      They will arrive at the CTRC at the Hospital of the University of Pennsylvania at 7 AM.&#xD;
      Starting at 8 AM, their blood will be drawn every four hours. A thin needle (an introducer)&#xD;
      will be inserted into a vein in their forearm, much like an IV line. Very small blood&#xD;
      samples, 10mL (2 teaspoonfuls), will be collected every four hours from 8:00 AM on Day 1&#xD;
      through 8:00 AM on Day 2. From this blood study staff will measure hormones related to&#xD;
      metabolism, sleep, and stress. They will be provided meals and snacks during this time, and&#xD;
      they are free to watch television or use their computer or participate in other sedentary&#xD;
      pastimes while they are there.&#xD;
&#xD;
      After the blood draws end at 8 AM on the second morning, their metabolic rate will be&#xD;
      measured. Participants will be asked to fast for 10 hours overnight (they will not be able to&#xD;
      eat or drink anything except water for 10 hours starting at 10 PM the night before). Then&#xD;
      study staff will measure their resting metabolic rate for 20 minutes. During the&#xD;
      measurements, they will lay on their back in bed with a plastic hood/canopy over their head&#xD;
      and neck. They will lay still and breathe normally while the air they inhale and exhale is&#xD;
      collected in the canopy/hood and analyzed using a machine that is connected to the&#xD;
      canopy/hood.&#xD;
&#xD;
      Participants will be discharged from the hospital, and research staff will escort them to the&#xD;
      Center for Weight and Eating Disorders where their body composition will be measured using&#xD;
      dual energy X-ray absorptiometry (DEXA). During this test, X-ray pictures of their body will&#xD;
      measure how much fat and muscle are present. They will lie flat on a table and a machine will&#xD;
      take pictures of different areas of the body. This test will last about 30 minutes. This will&#xD;
      conclude the assessment visit.&#xD;
&#xD;
      Eating Conditions &amp; Assessments Upon completion of the baseline assessment, participants will&#xD;
      be randomly assigned to start with one of two eating conditions: 1) Daytime or 2) Delayed,&#xD;
      and then they will switch and eat on the other schedule for the final part of the study. If&#xD;
      they are assigned to the Daytime eating condition first, they will be asked to consume all of&#xD;
      their meals and snacks each day between 8 AM and 7 PM. If they are assigned to the Delayed&#xD;
      eating condition first, they will be asked to consume all of their meals and snacks between&#xD;
      12 PM and 11 PM each day. They will eat on these schedules for 8 weeks each.&#xD;
&#xD;
      During the two 8-week eating condition periods, all of their meals and snacks will be&#xD;
      provided by the research kitchen and will be delivered to themby a member of the research&#xD;
      staff twice per week. They will be provided a personalized menu and asked to track each food&#xD;
      item they consume. They will also be asked to record any beverages they consume on this menu&#xD;
      (beverages will not be provided). If occasionally they do not eat the meals provided, they&#xD;
      will be asked to use their smart phone or electronic device to send a picture of their food&#xD;
      to the study team before they eat it, and again if any food is not eaten when they have&#xD;
      finished their meal. They will be asked to wear an Actigraph for the duration of the study,&#xD;
      and study staff will deliver new devices and collect used devices one time per week. They&#xD;
      will be sent and asked to respond to daily queries by text message or email regarding their&#xD;
      eating, sleeping, and exercise. At the end of the 8 weeks, they will complete the second&#xD;
      overnight assessment visit (as described above).&#xD;
&#xD;
      For two weeks following this second assessment, they will be asked to eat as they normally&#xD;
      would. During this &quot;wash-out&quot; period they will eat what and when then would like. They will&#xD;
      then complete the third overnight assessment visit before starting the second eating&#xD;
      condition (Delayed for those initially assigned to the Daytime schedule; Daytime for those&#xD;
      initially assigned to the Delayed schedule). They will be asked to eat on this new schedule&#xD;
      for 8 weeks. They will then complete the fourth and final overnight assessment. After this&#xD;
      final assessment visit, their participation in the study will be complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2014</start_date>
  <completion_date type="Actual">June 5, 2017</completion_date>
  <primary_completion_date type="Actual">June 4, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized within subjects, cross-over design</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daytime Vs. Delayed Eating</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>To determine if timing of food consumption (daytime vs. delayed eating) affects body mass (kg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory quotient</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Changes in fuel oxidation as measured by respiratory quotient with indirect calorimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Expenditure</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Changes in resting energy expenditure as measured by indirect calorimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of glucose</measure>
    <time_frame>ppre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of Insulin</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of cholesterol</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of triglycerides</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of adiponectin</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of adiponectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Levels of NEFA</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Fasting levels of non-esterified fatty acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition - total body fat</measure>
    <time_frame>pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks</time_frame>
    <description>Changes in total body fat measured using DEXA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Daytime Eating Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Eating Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eating Condition</intervention_name>
    <description>Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.</description>
    <arm_group_label>Daytime Eating Condition</arm_group_label>
    <arm_group_label>Delayed Eating Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults of all races and ethnicities&#xD;
&#xD;
          -  Age 21-45; BMI 20-27 kg/m2&#xD;
&#xD;
          -  stable weight (+/- 10 lbs) over the previous 6 months&#xD;
&#xD;
          -  Women must be pre-menopausal with regular menstrual cycles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular exercise more than 3 d/wk, for 30 min measured by exercise logs and actigraphy&#xD;
&#xD;
          -  normal activity levels are required throughout the study (+/-30 min/wk of baseline&#xD;
             level).&#xD;
&#xD;
          -  Unstable, serious medical conditions&#xD;
&#xD;
          -  use of medicine linked to weight gain/loss&#xD;
&#xD;
          -  cancer, diabetes, or autoimmune disease&#xD;
&#xD;
          -  use of illicit drugs, melatonin, diuretics or hypnotics&#xD;
&#xD;
          -  current weight loss program; presence of a sleep disorder (determined by surveys and&#xD;
             actigraphy)&#xD;
&#xD;
          -  night shift work; extreme chronotypes (extreme larks or night owls)&#xD;
&#xD;
          -  habitual waking outside of 0600 h-0930h&#xD;
&#xD;
          -  habitual bedtime outside of 2200h to 2400h&#xD;
&#xD;
          -  sleep duration outside of 6.5 to 8.5 h/night.&#xD;
&#xD;
          -  Psychiatric exclusions will be depression (Patient Health Questionnaire-9 score 9),&#xD;
             lifetime bipolar disorder, psychosis, or lifetime eating disorder; or any other severe&#xD;
             psychiatric disorder judged to interfere with study adherence as assessed by the&#xD;
             Structured Clinical Interview for the DSM-IV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly C Allison, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Perelman School of Medicine at the University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</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>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Kelly Allison</investigator_full_name>
    <investigator_title>Director, Center for Weight and Eating Disorders</investigator_title>
  </responsible_party>
  <keyword>Metabolism</keyword>
  <keyword>Eating</keyword>
  <keyword>Circadian Rhythms</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04414644/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04414644/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04414644
org study id: 820064
secondary id: R21DK100787
nct id: NCT04414644
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if, controlling for eating and sleep timing,
      caloric intake, and exercise, daytime vs. delayed eating affects body mass, adiposity, and
      energy metabolism in healthy adults.
The study consists of 4 phases - screening & baseline assessment, eating condition 1,
      wash-out period, and eating condition 2. Before and after each phase participants will
      complete a 28-hour inpatient assessment at the Clinical and Translational Research Center
      (CTRC) of the Hospital of the University of Pennsylvania to study the impact of one's eating
      on body weight and fat content, metabolism, and certain markers of metabolism in the blood.

      Screening In order to participate in this study the participants must undergo a complete
      physical examination and tests of blood and urine. These tests will determine if participants
      have any conditions that would prevent them from participating in the study, including
      diabetes or any serious uncontrolled medical condition that may interfere with their
      participation in the study. Other conditions that would prevent them from taking part are
      pregnancy or nursing, a sleep disorder, the use of certain medications, or night-shift work.
      A urine pregnancy test will be given to women at this screening visit.

      Participants will also complete several surveys of a psychological nature and participate in
      a clinical interview. Sleep and exercise schedules are important and will be reviewed during
      their visits to see if they match with the study requirements. During the 10 days of the
      screening assessment, participants will keep a log in which they will record all food and
      beverages that they consume. They will also use these logs to record when they sleep and
      exercise. Their activity will be measured by a small electronic wrist activity recorder,
      called an Actigraph (about the size of a wrist watch), during this time. This recorder,
      similar to a pedometer, records all activity from the arm, and is very useful in determining
      if and when they get up at night. Study staff will explain how to keep this information
      during the baseline visit. They will return the activity recorder and log to Dr. Allison for
      analysis at the end of the 10-days. They are expected to return all study materials,
      including the Actigraph, log, and questionnaires.

      Assessments Following successful completion of the screening period, they will complete the
      first of four assessment visits. This visit will include 28 hours (overnight) spent at the
      CTRC, where their meals and snacks will be provided.

      They will arrive at the CTRC at the Hospital of the University of Pennsylvania at 7 AM.
      Starting at 8 AM, their blood will be drawn every four hours. A thin needle (an introducer)
      will be inserted into a vein in their forearm, much like an IV line. Very small blood
      samples, 10mL (2 teaspoonfuls), will be collected every four hours from 8:00 AM on Day 1
      through 8:00 AM on Day 2. From this blood study staff will measure hormones related to
      metabolism, sleep, and stress. They will be provided meals and snacks during this time, and
      they are free to watch television or use their computer or participate in other sedentary
      pastimes while they are there.

      After the blood draws end at 8 AM on the second morning, their metabolic rate will be
      measured. Participants will be asked to fast for 10 hours overnight (they will not be able to
      eat or drink anything except water for 10 hours starting at 10 PM the night before). Then
      study staff will measure their resting metabolic rate for 20 minutes. During the
      measurements, they will lay on their back in bed with a plastic hood/canopy over their head
      and neck. They will lay still and breathe normally while the air they inhale and exhale is
      collected in the canopy/hood and analyzed using a machine that is connected to the
      canopy/hood.

      Participants will be discharged from the hospital, and research staff will escort them to the
      Center for Weight and Eating Disorders where their body composition will be measured using
      dual energy X-ray absorptiometry (DEXA). During this test, X-ray pictures of their body will
      measure how much fat and muscle are present. They will lie flat on a table and a machine will
      take pictures of different areas of the body. This test will last about 30 minutes. This will
      conclude the assessment visit.

      Eating Conditions & Assessments Upon completion of the baseline assessment, participants will
      be randomly assigned to start with one of two eating conditions: 1) Daytime or 2) Delayed,
      and then they will switch and eat on the other schedule for the final part of the study. If
      they are assigned to the Daytime eating condition first, they will be asked to consume all of
      their meals and snacks each day between 8 AM and 7 PM. If they are assigned to the Delayed
      eating condition first, they will be asked to consume all of their meals and snacks between
      12 PM and 11 PM each day. They will eat on these schedules for 8 weeks each.

      During the two 8-week eating condition periods, all of their meals and snacks will be
      provided by the research kitchen and will be delivered to themby a member of the research
      staff twice per week. They will be provided a personalized menu and asked to track each food
      item they consume. They will also be asked to record any beverages they consume on this menu
      (beverages will not be provided). If occasionally they do not eat the meals provided, they
      will be asked to use their smart phone or electronic device to send a picture of their food
      to the study team before they eat it, and again if any food is not eaten when they have
      finished their meal. They will be asked to wear an Actigraph for the duration of the study,
      and study staff will deliver new devices and collect used devices one time per week. They
      will be sent and asked to respond to daily queries by text message or email regarding their
      eating, sleeping, and exercise. At the end of the 8 weeks, they will complete the second
      overnight assessment visit (as described above).

      For two weeks following this second assessment, they will be asked to eat as they normally
      would. During this "wash-out" period they will eat what and when then would like. They will
      then complete the third overnight assessment visit before starting the second eating
      condition (Delayed for those initially assigned to the Daytime schedule; Daytime for those
      initially assigned to the Delayed schedule). They will be asked to eat on this new schedule
      for 8 weeks. They will then complete the fourth and final overnight assessment. After this
      final assessment visit, their participation in the study will be complete.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized within subjects, cross-over design
primary purpose: Other
masking: None (Open Label)
measure: Daytime Vs. Delayed Eating
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: To determine if timing of food consumption (daytime vs. delayed eating) affects body mass (kg).
measure: Respiratory quotient
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Changes in fuel oxidation as measured by respiratory quotient with indirect calorimetry.
measure: Energy Expenditure
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Changes in resting energy expenditure as measured by indirect calorimetry.
measure: Fasting Levels of glucose
time frame: ppre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of glucose
measure: Fasting Levels of Insulin
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of insulin
measure: Fasting Levels of cholesterol
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of cholesterol
measure: Fasting Levels of triglycerides
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of triglycerides
measure: Fasting Levels of adiponectin
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of adiponectin
measure: Fasting Levels of NEFA
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Fasting levels of non-esterified fatty acids
measure: Body Composition - total body fat
time frame: pre-post changes between the daytime and delayed eating conditions; baseline to 8 weeks
description: Changes in total body fat measured using DEXA
arm group label: Daytime Eating Condition
arm group type: Experimental
description: Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
arm group label: Delayed Eating Condition
arm group type: Experimental
description: Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
intervention type: Behavioral
intervention name: Eating Condition
description: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
arm group label: Daytime Eating Condition
arm group label: Delayed Eating Condition
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly C Allison, PhD
role: Principal Investigator
affiliation: Perelman School of Medicine at the University of Pennsylvania
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Kelly Allison
investigator title: Director, Center for Weight and Eating Disorders
sharing ipd: No
provided document: 
provided document: 