<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/NCT01682317</url>
  </required_header>
  <id_info>
    <org_study_id>UTK IRB# FWA 6629</org_study_id>
    <nct_id>NCT01682317</nct_id>
  </id_info>
  <brief_title>Healthy Eating Patterns During a Lifestyle Intervention</brief_title>
  <acronym>HEP</acronym>
  <official_title>Healthy Eating Patterns During a Lifestyle Intervention</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>
      The purpose of this study is to address the gap in knowledge regarding the relationship&#xD;
      between eating frequency and weight loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little intervention research has been conducted to examine the influence of eating frequency&#xD;
      (EF) on weight loss. It has been hypothesized an increased EF improves appetite control,&#xD;
      assisting with better regulation of energy intake, thus decreasing body mass index.&#xD;
      Unfortunately, outcomes have not shown greater appetite control with increased EF. Instead,&#xD;
      trends favor a lower EF reducing energy intake thereby producing greater weight loss than a&#xD;
      higher eating frequency. Thus, a lower eating frequency may lower energy intake via&#xD;
      behavioral mechanisms. At thit time no research has examined the behavioral mechanisms that&#xD;
      may mediate the relationship between a lower eating frequency and superior adherence to an&#xD;
      energy-restricted diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diet</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Diet (eating frequency, kilocalories, macronutrients)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ecological Momentary Assessment (EMA)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Height (0 weeks only), weight and body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge Eating</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Three Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grazing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the increased eating frequency condition will be instructed to eat &gt; 100 kcals every 2-3 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eating Frequency</intervention_name>
    <description>Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, &lt; 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 EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).</description>
    <arm_group_label>Grazing</arm_group_label>
    <arm_group_label>Three Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 65 years&#xD;
&#xD;
          -  healthy overweight and obese men and women&#xD;
&#xD;
          -  body mass index (BMI) between 27 and 45 kg/m squared&#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;
          -  diagnosed with type 1 or 2 diabetes&#xD;
&#xD;
          -  have had bariatric surgery or are planning to have bariatric surgery in 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hollie A Raynor, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthy Eating and Activity Laboratory, University of Tennessee</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>June 2023</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</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>Professor</investigator_title>
  </responsible_party>
  <keyword>eating frequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01682317
org study id: UTK IRB# FWA 6629
nct id: NCT01682317
lead sponsor: 
has dmc: Yes
The purpose of this study is to address the gap in knowledge regarding the relationship
      between eating frequency and weight loss.
Little intervention research has been conducted to examine the influence of eating frequency
      (EF) on weight loss. It has been hypothesized an increased EF improves appetite control,
      assisting with better regulation of energy intake, thus decreasing body mass index.
      Unfortunately, outcomes have not shown greater appetite control with increased EF. Instead,
      trends favor a lower EF reducing energy intake thereby producing greater weight loss than a
      higher eating frequency. Thus, a lower eating frequency may lower energy intake via
      behavioral mechanisms. At thit time no research has examined the behavioral mechanisms that
      may mediate the relationship between a lower eating frequency and superior adherence to an
      energy-restricted diet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Diet
time frame: 0 and 8 weeks
description: Diet (eating frequency, kilocalories, macronutrients)
measure: Ecological Momentary Assessment (EMA)
time frame: 0 and 8 weeks
description: To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.
measure: Anthropometrics
time frame: 0 and 8 weeks
description: Height (0 weeks only), weight and body mass index
measure: Binge Eating
time frame: 0 and 8 weeks
description: Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.
measure: Physical Activity
time frame: 0 and 8 weeks
description: Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.
arm group label: Three Meal
arm group type: Experimental
description: Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.
arm group label: Grazing
arm group type: Experimental
description: Participants in the increased eating frequency condition will be instructed to eat > 100 kcals every 2-3 hours.
intervention type: Behavioral
intervention name: Eating Frequency
description: 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 EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).
arm group label: Grazing
arm group label: Three Meal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hollie A Raynor, PhD, 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: Professor
mesh term: Weight Loss