<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/NCT01724632</url>
  </required_header>
  <id_info>
    <org_study_id>1R01DK095779</org_study_id>
    <nct_id>NCT01724632</nct_id>
  </id_info>
  <brief_title>LIVE SMART: Smartphone Intervention for Weight Control</brief_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 purpose of this study is to compare three methods of delivering behavioral weight loss&#xD;
      treatment.Participants are randomly assigned to one of three 18-month weight loss treatments&#xD;
      (group, individual, or smartphone treatment). Participants who are assigned to group&#xD;
      treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6&#xD;
      months, and then monthly for the final 6 months. Participants who are assigned to individual&#xD;
      treatment will attend one-on-one sessions with a weight loss counselor every month for 18&#xD;
      months. Participants who are assigned to smartphone treatment will use a smartphone to learn&#xD;
      and practice weight loss skills. They will also attend one-on-one sessions with a weight loss&#xD;
      counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and&#xD;
      18 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>Change from baseline to 18-months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight-related Behaviors</measure>
    <time_frame>Change from baseline to 18-months.</time_frame>
    <description>Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Engagement with Smartphone Treatment system</measure>
    <time_frame>Mueasured continuously for the 18-month treatment.</time_frame>
    <description>Frequency and duration of use of intervention resources made available to the smartphone treatment arm.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">276</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smartphone Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Counseling</intervention_name>
    <description>Participants receive instructions for making healthy changes to their diet and physical activity habits.</description>
    <arm_group_label>Group Treatment</arm_group_label>
    <arm_group_label>Individual Treatment</arm_group_label>
    <arm_group_label>Smartphone Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (kg/m2) of 25-45.&#xD;
&#xD;
          -  English language fluency&#xD;
&#xD;
          -  Ability to read at a 6th grade level&#xD;
&#xD;
          -  Availability to attend weekly treatment sessions in Providence, RI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any heart condition that limits ability to participate in physical activity&#xD;
&#xD;
          -  Chest Pain&#xD;
&#xD;
          -  Any cognitive of physical limitation that would preclude use of a smartphone&#xD;
&#xD;
          -  Serious mental illness&#xD;
&#xD;
          -  Historical or current eating disorder&#xD;
&#xD;
          -  Previous or planned bariatric surgery&#xD;
&#xD;
          -  Use of weight loss medication&#xD;
&#xD;
          -  Recent pregnancy or a plan to become pregnant in the next 6 months&#xD;
&#xD;
          -  Participation in a study at the Weight Control and Diabetes Research Center within the&#xD;
             last two years&#xD;
&#xD;
          -  A weight loss of greater than 5% body weight in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Weight Control and Diabetes Resarch 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>May 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>John Graham Thomas</investigator_full_name>
    <investigator_title>Assistant Professor (Research)</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Weight Loss</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/NCT01724632
org study id: 1R01DK095779
nct id: NCT01724632
lead sponsor: 
has dmc: No
The purpose of this study is to compare three methods of delivering behavioral weight loss
      treatment.Participants are randomly assigned to one of three 18-month weight loss treatments
      (group, individual, or smartphone treatment). Participants who are assigned to group
      treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6
      months, and then monthly for the final 6 months. Participants who are assigned to individual
      treatment will attend one-on-one sessions with a weight loss counselor every month for 18
      months. Participants who are assigned to smartphone treatment will use a smartphone to learn
      and practice weight loss skills. They will also attend one-on-one sessions with a weight loss
      counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and
      18 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Loss
time frame: Change from baseline to 18-months.
measure: Weight-related Behaviors
time frame: Change from baseline to 18-months.
description: Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.
measure: Engagement with Smartphone Treatment system
time frame: Mueasured continuously for the 18-month treatment.
description: Frequency and duration of use of intervention resources made available to the smartphone treatment arm.
arm group label: Group Treatment
arm group type: Active Comparator
description: Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.
arm group label: Individual Treatment
arm group type: Active Comparator
description: Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
arm group label: Smartphone Treatment
arm group type: Experimental
description: Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.
intervention type: Behavioral
intervention name: Lifestyle Counseling
description: Participants receive instructions for making healthy changes to their diet and physical activity habits.
arm group label: Group Treatment
arm group label: Individual Treatment
arm group label: Smartphone Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: John Graham Thomas
investigator title: Assistant Professor (Research)
mesh term: Overweight