<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/NCT01717352</url>
  </required_header>
  <id_info>
    <org_study_id>U01CA150387-Study 5</org_study_id>
    <secondary_id>U01CA150387</secondary_id>
    <nct_id>NCT01717352</nct_id>
  </id_info>
  <brief_title>Sleep Plus Eating Routines for Weight Loss</brief_title>
  <official_title>Increasing Sleep Duration: A Novel Approach to Weight Control. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will test the effectiveness of two different approaches for preparing&#xD;
      overweight/obese individuals for weight loss: 1)providing important information about weight&#xD;
      control, including dispelling common myths; or 2) developing a consistent sleep and eating&#xD;
      routine to prepare for the challenges of a weight control intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2</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>Weight</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Executive Control</measure>
    <time_frame>4 and 20 weeks</time_frame>
    <description>Executive control is measured by a variety of computer assessments. These include Go-No Go, delayed discounting, and perseverence as measured by mirror tracing and a hand grip task.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Weight Loss Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep and Eating Routine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss Education</intervention_name>
    <arm_group_label>Weight Loss Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep and Eating Routine</intervention_name>
    <arm_group_label>Sleep and Eating Routine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 21 to 65&#xD;
&#xD;
          -  BMI 25 to 45&#xD;
&#xD;
          -  sleep 7 hours or less most nights&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of medications affecting sleep&#xD;
&#xD;
          -  sleep apnea&#xD;
&#xD;
          -  shift work&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rena R Wing, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weight Control &amp; Diabetes Research Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Rena R. Wing</investigator_full_name>
    <investigator_title>Professor of Psychiatry &amp; Human Behavior</investigator_title>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT01717352
org study id: U01CA150387-Study 5
secondary id: U01CA150387
nct id: NCT01717352
lead sponsor: 
has dmc: No
The present study will test the effectiveness of two different approaches for preparing
      overweight/obese individuals for weight loss: 1)providing important information about weight
      control, including dispelling common myths; or 2) developing a consistent sleep and eating
      routine to prepare for the challenges of a weight control intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Weight
time frame: 20 weeks
measure: Executive Control
time frame: 4 and 20 weeks
description: Executive control is measured by a variety of computer assessments. These include Go-No Go, delayed discounting, and perseverence as measured by mirror tracing and a hand grip task.
arm group label: Weight Loss Education
arm group type: Active Comparator
description: Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
arm group label: Sleep and Eating Routine
arm group type: Active Comparator
description: Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
intervention type: Behavioral
intervention name: Weight Loss Education
arm group label: Weight Loss Education
intervention type: Behavioral
intervention name: Sleep and Eating Routine
arm group label: Sleep and Eating Routine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rena R Wing, PhD
role: Principal Investigator
affiliation: The Miriam Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Rena R. Wing
investigator title: Professor of Psychiatry & Human Behavior
mesh term: Overweight
mesh term: Weight Loss