<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/NCT02204735</url>
  </required_header>
  <id_info>
    <org_study_id>UTK_9560 B</org_study_id>
    <nct_id>NCT02204735</nct_id>
  </id_info>
  <brief_title>Timing of Meals for Weight Loss</brief_title>
  <acronym>TIME</acronym>
  <official_title>Timing of Meals for Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While eating the majority of energy earlier in the day appears to have a positive effect on&#xD;
      weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences&#xD;
      other behaviors that have a circadian rhythm (sleep), other energy balance behaviors&#xD;
      important for weight loss (physical activity), and self-reported feelings of appetite control&#xD;
      (hunger and fullness). Thus the purpose of this study is to examine the influence of timing&#xD;
      of eating on sleep patterns, physical activity, and self-reported feelings of appetite&#xD;
      control. It is hypothesized that those who eat the majority of their calories earlier in the&#xD;
      day will have greater weight loss than those who eat the majority later in the day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a&#xD;
      1200-1500 kcal/day, &lt; 30% energy from fat dietary prescription, and a physical activity goal&#xD;
      of 200 minutes/week. Participants will be randomized to one of two conditions differing in&#xD;
      timing of energy consumed during eating bouts. Both conditions will limit the number of&#xD;
      eating bouts/day to three. Participants will be instructed to eat their first eating bout&#xD;
      within one hour of awakening and to consume their second and third eating bouts within five&#xD;
      or six hours of their previous bout. Participants will be discouraged from eating at least&#xD;
      one hour prior to going to sleep. During the intervention, participants will be instructed to&#xD;
      self-monitor the time they wake up, the time of the start of each eating bout, and time they&#xD;
      go to bed, as well as foods and beverages, and portion sizes, consumed. One condition will&#xD;
      consume more energy earlier in the day (MORNING), thus energy intake will be split amongst&#xD;
      the three eating bouts with 50% in the first bout, 30% in the second bout, and 20% in the&#xD;
      last bout. The second condition will consume more energy later in the day (EVENING), thus&#xD;
      energy intake will be split amongst the three eating bouts with 20% in the first bout, 30% in&#xD;
      the second bout, and 50% in the last bout.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Weight will be assessed by an electronic scale, and height will be assessed using a stadiometer, using standard procedures, with participants wearing light clothing, without shoes. BMI (kg/m2) will be calculated from these measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>the SenseWear® armband from BodyMedia will measure physical activity-related energy expenditure for the course of the study. Energy expenditure will be calculated using the corresponding software. This armband reports physical activity in total minutes and joules expended. Furthermore, this armband reports minutes of physical activity divided into 5 categories: sedentary activities (&lt;1.5 METS), light physical activity (1.5-2.9 METS), moderate activity (3.0-5.9 METS), vigorous activity (6.0-8.9 METS), and very vigorous activity (≥9.0 METS). Minutes of active energy expenditure are also reported, which includes total number of minutes engaged in moderate, vigorous, or very vigorous activity. For each participant, mean minutes of sedentary, light, moderate, and vigorous activity (vigorous activity + very vigorous activity) will be calculated over the course of the 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>participants will be instructed to wear the SenseWear® armband from BodyMedia® on their upper left arm for 7 days. Participants will be instructed to wear the armband for 23 hours a day for each of the 7-day time frames. The SenseWear® has been shown to be a reliable measurement for total sleep time in both individuals with and without obstructive sleep apnea. The SenseWear® armband recognizes the onset of sleep when there is a drop in the heat flux sensor (arm skin temperature).16 The BodyMedia® software then codes the output from the SenseWear® as either wake or sleep (regardless of sleep stage) binary codes,15 based on manufacturer sleep algorithms.16 The armband reports total minutes of lying down and total minutes wake/sleep during the lying down time, allowing sleep efficiency to be calculated. For each participant, minutes of sleep per 24 hrs and mean sleep efficiency will be calculated from the 7 days of measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diet</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Energy and macronutrient intake overall and per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. Eating bouts will only be counted if at least 25 kcals were consumed. All foods and beverages, eaten within 1/2 h of the start of a meal, will be counted as a single eating bout. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>feelings of hunger and fullness</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation. Event-based sampling will assess these same cues and feelings, as well as reasons for initiating and terminating eating, Time-based and event-based sampling questions will be programmed and displayed using Satellite Forms™ MobileApp Designer software (Thacker Network Technologies Inc., Alberta, Canada).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>MORNING</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be instructed to consume 50% of their energy intake in their first eating bout, 30% in their second eating bout, and 20% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 600 kcal in their first eating bout, 360 kcal in their second bout, and 240 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVENING</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be instructed to consume 20% of their energy intake in their first eating bout, 30% in their second eating bout, and 50% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 240 kcal in their first eating bout, 360 kcal in their second bout, and 600 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eat majority of calories in the morning</intervention_name>
    <arm_group_label>MORNING</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eat the majority of calories in the evening</intervention_name>
    <arm_group_label>EVENING</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index (BMI) between 27 and 45 kg/m2&#xD;
&#xD;
          -  normal self-reported daily (weekday and weekend) wake-up time between 5 am and 8 am&#xD;
&#xD;
          -  normal, self-reported weekend wake-up time within two hours of their normal,&#xD;
             self-reported weekday wake-up time&#xD;
&#xD;
          -  regularly (at least five nights/week) get at least six total hours of self-reported&#xD;
             sleep&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  report a heart condition, chest pain during periods of activity or rest, or loss of&#xD;
             consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)&#xD;
&#xD;
          -  report being unable to walk for 2 blocks (1/4 mile) without stopping&#xD;
&#xD;
          -  are currently participating in a weight loss program and/or taking weight loss&#xD;
             medication or lost &gt; 5% of body weight during the past 6 months&#xD;
&#xD;
          -  are diagnosed with type 1 or 2 diabetes&#xD;
&#xD;
          -  have had bariatric surgery or are planning to have bariatric surgery within the next 4&#xD;
             months&#xD;
&#xD;
          -  intend to move outside of the metropolitan area within the time frame of the&#xD;
             investigation&#xD;
&#xD;
          -  are pregnant, lactating, &lt; 6 months post-partum, or plan to become pregnant during the&#xD;
             investigation&#xD;
&#xD;
          -  are taking mediation to aid in sleep&#xD;
&#xD;
          -  are shift workers/alternative shift workers that work outside of 7 am and 7 pm&#xD;
&#xD;
          -  have a metal allergy (which would prevent the ability of participant to wear the&#xD;
             SenseWear® armband from BodyMedia® used in the proposed study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hollie Raynor, Ph, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Tennessee--HEAL Lab</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Meal Time</keyword>
  <keyword>Weight Loss</keyword>
  <keyword>Circadian Rhythm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT02204735
org study id: UTK_9560 B
nct id: NCT02204735
lead sponsor: 
has dmc: Yes
While eating the majority of energy earlier in the day appears to have a positive effect on
      weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences
      other behaviors that have a circadian rhythm (sleep), other energy balance behaviors
      important for weight loss (physical activity), and self-reported feelings of appetite control
      (hunger and fullness). Thus the purpose of this study is to examine the influence of timing
      of eating on sleep patterns, physical activity, and self-reported feelings of appetite
      control. It is hypothesized that those who eat the majority of their calories earlier in the
      day will have greater weight loss than those who eat the majority later in the day.
Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a
      1200-1500 kcal/day, < 30% energy from fat dietary prescription, and a physical activity goal
      of 200 minutes/week. Participants will be randomized to one of two conditions differing in
      timing of energy consumed during eating bouts. Both conditions will limit the number of
      eating bouts/day to three. Participants will be instructed to eat their first eating bout
      within one hour of awakening and to consume their second and third eating bouts within five
      or six hours of their previous bout. Participants will be discouraged from eating at least
      one hour prior to going to sleep. During the intervention, participants will be instructed to
      self-monitor the time they wake up, the time of the start of each eating bout, and time they
      go to bed, as well as foods and beverages, and portion sizes, consumed. One condition will
      consume more energy earlier in the day (MORNING), thus energy intake will be split amongst
      the three eating bouts with 50% in the first bout, 30% in the second bout, and 20% in the
      last bout. The second condition will consume more energy later in the day (EVENING), thus
      energy intake will be split amongst the three eating bouts with 20% in the first bout, 30% in
      the second bout, and 50% in the last bout.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight
time frame: 0 and 8 weeks
description: Weight will be assessed by an electronic scale, and height will be assessed using a stadiometer, using standard procedures, with participants wearing light clothing, without shoes. BMI (kg/m2) will be calculated from these measures.
measure: physical activity
time frame: 0 and 8 weeks
description: the SenseWear® armband from BodyMedia will measure physical activity-related energy expenditure for the course of the study. Energy expenditure will be calculated using the corresponding software. This armband reports physical activity in total minutes and joules expended. Furthermore, this armband reports minutes of physical activity divided into 5 categories: sedentary activities (<1.5 METS), light physical activity (1.5-2.9 METS), moderate activity (3.0-5.9 METS), vigorous activity (6.0-8.9 METS), and very vigorous activity (≥9.0 METS). Minutes of active energy expenditure are also reported, which includes total number of minutes engaged in moderate, vigorous, or very vigorous activity. For each participant, mean minutes of sedentary, light, moderate, and vigorous activity (vigorous activity + very vigorous activity) will be calculated over the course of the 7 days.
measure: sleep
time frame: 0 and 8 weeks
description: participants will be instructed to wear the SenseWear® armband from BodyMedia® on their upper left arm for 7 days. Participants will be instructed to wear the armband for 23 hours a day for each of the 7-day time frames. The SenseWear® has been shown to be a reliable measurement for total sleep time in both individuals with and without obstructive sleep apnea. The SenseWear® armband recognizes the onset of sleep when there is a drop in the heat flux sensor (arm skin temperature).16 The BodyMedia® software then codes the output from the SenseWear® as either wake or sleep (regardless of sleep stage) binary codes,15 based on manufacturer sleep algorithms.16 The armband reports total minutes of lying down and total minutes wake/sleep during the lying down time, allowing sleep efficiency to be calculated. For each participant, minutes of sleep per 24 hrs and mean sleep efficiency will be calculated from the 7 days of measures.
measure: diet
time frame: 0 and 8 weeks
description: Energy and macronutrient intake overall and per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. Eating bouts will only be counted if at least 25 kcals were consumed. All foods and beverages, eaten within 1/2 h of the start of a meal, will be counted as a single eating bout. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
measure: feelings of hunger and fullness
time frame: 0 and 8 weeks
description: EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation. Event-based sampling will assess these same cues and feelings, as well as reasons for initiating and terminating eating, Time-based and event-based sampling questions will be programmed and displayed using Satellite Forms™ MobileApp Designer software (Thacker Network Technologies Inc., Alberta, Canada).
arm group label: MORNING
arm group type: Experimental
description: Participants will be instructed to consume 50% of their energy intake in their first eating bout, 30% in their second eating bout, and 20% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 600 kcal in their first eating bout, 360 kcal in their second bout, and 240 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.
arm group label: EVENING
arm group type: Experimental
description: Participants will be instructed to consume 20% of their energy intake in their first eating bout, 30% in their second eating bout, and 50% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 240 kcal in their first eating bout, 360 kcal in their second bout, and 600 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.
intervention type: Behavioral
intervention name: Eat majority of calories in the morning
arm group label: MORNING
intervention type: Behavioral
intervention name: Eat the majority of calories in the evening
arm group label: EVENING
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hollie Raynor, Ph, RD
role: Principal Investigator
affiliation: University of Tennessee
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Principal Investigator
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Loss