<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/NCT02189187</url>
  </required_header>
  <id_info>
    <org_study_id>5R34AT006963</org_study_id>
    <nct_id>NCT02189187</nct_id>
  </id_info>
  <brief_title>Keeping Weight Off: Brain Changes Associated With Healthy Behaviors</brief_title>
  <official_title>Keeping Weight Off: Brain Changes Associated With Healthy Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to characterize changes in emotion regulation pathways associated&#xD;
      with healthy behaviors in people who have recently lost weight and are seeking to maintain&#xD;
      weight loss over a 1-year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for&#xD;
      overweight and obesity which substantially increase risk for chronic conditions such as heart&#xD;
      disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise&#xD;
      in obesity threatens to reverse recent gains in life expectancy and account for a large&#xD;
      percentage of premature deaths in the U.S. Although there is evidence for the short-term&#xD;
      efficacy of a number of methods for initiating health behavior change to lose weight, these&#xD;
      interventions have shown only limited ability to affect significant, long-term behavioral&#xD;
      changes in the majority of adults. In part this may be because they fail to adequately&#xD;
      address how psychological factors that lead to relapse to unhealthy behaviors and failure to&#xD;
      maintain long-term behavior change.&#xD;
&#xD;
      The purpose of the study is to understand brain changes that accompany participation in&#xD;
      programs that foster healthy behaviors in people seeking to maintain weight loss. We will use&#xD;
      MRI scans to study brain function in men and women 25-60 years old who have lost weight in&#xD;
      the last year without surgery. Participants will be assigned to one of two programs to help&#xD;
      them maintain weight loss and will be compensated for their time. Our goal is to gain a&#xD;
      better understanding of the brain changes that lead to long-term success in keeping weight&#xD;
      off, in the hope that this knowledge will assist in the development of improved treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional connectivity on fMRI</measure>
    <time_frame>8 weeks</time_frame>
    <description>Functional Magnetic Resonance Imaging (fMRI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association of functional connectivity change with changes in depression symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Center for Epidemiological Studies-Depression Scale (CES-D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of functional connectivity with maintenance of weight loss</measure>
    <time_frame>6 months</time_frame>
    <description>BMI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Mindfulness Based Stress Reduction (MBSR) program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness Based Stress Reduction (MBSR) is an 8-week program that consists of training in mindfulness practices, the application of mindfulness to daily life, and information about healthy living and the role played by thoughts and emotions in health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Living Course (HLC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy Living Course (HLC) an 8-week psycho-educational program that consists of lectures and discussion on healthy living, stress management, time management, and unhealthy behaviors (e.g. smoking, drinking).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <arm_group_label>Mindfulness Based Stress Reduction (MBSR) program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <arm_group_label>Healthy Living Course (HLC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  25 to 60 years old&#xD;
&#xD;
          -  Healthy individuals who have intentionally lost at least 5% of their body weight over&#xD;
             the past year&#xD;
&#xD;
          -  BMI &gt;20.5 kg/m2 at study entry and &gt;25 in past 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight-loss surgery or medications&#xD;
&#xD;
          -  Serious Psychiatric or medical conditions&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Ineligible for MRI&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Eating disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Umass Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Carl Fulwiler</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Weight Loss</keyword>
  <keyword>Body Weight Changes</keyword>
  <keyword>Body Weight</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Emotions</keyword>
  <keyword>Emotion regulation</keyword>
  <keyword>Health Behavior</keyword>
  <keyword>Eating behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02189187
org study id: 5R34AT006963
nct id: NCT02189187
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this project is to characterize changes in emotion regulation pathways associated
      with healthy behaviors in people who have recently lost weight and are seeking to maintain
      weight loss over a 1-year period.
Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for
      overweight and obesity which substantially increase risk for chronic conditions such as heart
      disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise
      in obesity threatens to reverse recent gains in life expectancy and account for a large
      percentage of premature deaths in the U.S. Although there is evidence for the short-term
      efficacy of a number of methods for initiating health behavior change to lose weight, these
      interventions have shown only limited ability to affect significant, long-term behavioral
      changes in the majority of adults. In part this may be because they fail to adequately
      address how psychological factors that lead to relapse to unhealthy behaviors and failure to
      maintain long-term behavior change.

      The purpose of the study is to understand brain changes that accompany participation in
      programs that foster healthy behaviors in people seeking to maintain weight loss. We will use
      MRI scans to study brain function in men and women 25-60 years old who have lost weight in
      the last year without surgery. Participants will be assigned to one of two programs to help
      them maintain weight loss and will be compensated for their time. Our goal is to gain a
      better understanding of the brain changes that lead to long-term success in keeping weight
      off, in the hope that this knowledge will assist in the development of improved treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Functional connectivity on fMRI
time frame: 8 weeks
description: Functional Magnetic Resonance Imaging (fMRI)
measure: Association of functional connectivity change with changes in depression symptoms
time frame: 6 months
description: Center for Epidemiological Studies-Depression Scale (CES-D)
measure: Association of functional connectivity with maintenance of weight loss
time frame: 6 months
description: BMI
arm group label: Mindfulness Based Stress Reduction (MBSR) program
arm group type: Experimental
description: Mindfulness Based Stress Reduction (MBSR) is an 8-week program that consists of training in mindfulness practices, the application of mindfulness to daily life, and information about healthy living and the role played by thoughts and emotions in health.
arm group label: Healthy Living Course (HLC)
arm group type: Active Comparator
description: Healthy Living Course (HLC) an 8-week psycho-educational program that consists of lectures and discussion on healthy living, stress management, time management, and unhealthy behaviors (e.g. smoking, drinking).
intervention type: Behavioral
intervention name: Mindfulness
arm group label: Mindfulness Based Stress Reduction (MBSR) program
intervention type: Behavioral
intervention name: Psychoeducation
arm group label: Healthy Living Course (HLC)
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Carl Fulwiler
investigator title: Associate Professor of Psychiatry
mesh term: Overweight