<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/NCT04447313</url>
  </required_header>
  <id_info>
    <org_study_id>RG1007177</org_study_id>
    <secondary_id>NCI-2020-01624</secondary_id>
    <secondary_id>10404</secondary_id>
    <secondary_id>R01DK124114</secondary_id>
    <nct_id>NCT04447313</nct_id>
  </id_info>
  <brief_title>Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study</brief_title>
  <official_title>Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial compares telephone delivered Acceptance and Commitment Therapy to&#xD;
      standard behavioral therapy for improving weight loss in overweight or obese participants.&#xD;
      Acceptance and Commitment Therapy focuses on increasing willingness to experience physical&#xD;
      cravings, emotions, and thoughts while making values-guided committed behavior changes.&#xD;
      Acceptance and Commitment Therapy may work better at improving weight loss compared to&#xD;
      standard behavioral therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Participants are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16&#xD;
      weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration,&#xD;
      while calls 2-25 are each 15-20 minutes in duration.&#xD;
&#xD;
      ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16&#xD;
      weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration,&#xD;
      while calls 2-25 are each 15-20 minutes in duration.&#xD;
&#xD;
      Participants are followed up at 6, 12, and 24 months after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 5, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>10% or more weight loss</measure>
    <time_frame>At 12 months after randomization</time_frame>
    <description>Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent weight change</measure>
    <time_frame>At 6, 12, and 24-months post randomization</time_frame>
    <description>Will be measured remotely by cellular-enabled scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>At 6, 12, and 24-months post randomization</time_frame>
    <description>Will be measured with the Fitbit smartphone app food logging feature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>At 6, 12, and 24-months post randomization</time_frame>
    <description>Will be measured with the Fitbit Inspire mailed to participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectories of weight change</measure>
    <time_frame>At 6, 12, and 24-months post randomization</time_frame>
    <description>Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">398</enrollment>
  <condition>Obesity-Related Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Arm I (ACT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (SBT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (ACT)</arm_group_label>
    <arm_group_label>Arm II (SBT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive ACT telephone coaching</description>
    <arm_group_label>Arm I (ACT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive SBT telephone coaching</description>
    <arm_group_label>Arm II (SBT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese (body mass index [BMI] &gt;= 27) but not heavier than BMI of 45.5&#xD;
             (measured by weight &amp; height)&#xD;
&#xD;
          -  Wants to lose weight in the next 30 days&#xD;
&#xD;
          -  Interested in learning skills to lose weight&#xD;
&#xD;
          -  Willing to be randomly assigned to either condition&#xD;
&#xD;
          -  Resides in United States (US)&#xD;
&#xD;
          -  Has daily access to their own phone and email&#xD;
&#xD;
          -  Does not have a medical or psychiatric condition that would limit their ability to&#xD;
             comply with the behavioral recommendations of the program or pose a risk to the&#xD;
             participant during weight loss, including meeting criteria for binge eating disorder,&#xD;
             and meeting criteria for severe depression (CESD &gt;= 25), or a diagnosis of serious&#xD;
             heart disease, diabetes, uncontrolled hypertension, or cancer without written&#xD;
             confirmation of approval from their physician office&#xD;
&#xD;
          -  Not pregnant, planning to become pregnant or breastfeeding in the next 12 months&#xD;
&#xD;
          -  In the past 3 months changed the dosage of prescription medications that can cause a&#xD;
             significant change in weight or appetite&#xD;
&#xD;
          -  Have not lost more than 5% of their weight in the past 6 months&#xD;
&#xD;
          -  Willing and able to read in English&#xD;
&#xD;
          -  Not participating in or planning to participate in other weight loss programs&#xD;
&#xD;
          -  Has not participated in our other ACT intervention studies&#xD;
&#xD;
          -  Does not meet criteria for combined heavy plus binge drinking&#xD;
&#xD;
          -  Has access to a Bluetooth-enabled device and Wi-Fi and/or data plan&#xD;
&#xD;
          -  Is not planning to have or has not recently had (past 12 months) bariatric surgery&#xD;
&#xD;
          -  For outcome data retention, eligibility criteria included: Willing to complete&#xD;
             follow-up surveys, and provide email, phone, and mailing address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The reverse of the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan B Bricker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brie Sullivan</last_name>
    <phone>206-667-5238</phone>
    <email>bsulliva@fredhutch.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brie Sullivan</last_name>
      <phone>206-667-5238</phone>
      <email>bsulliva@fredhutch.org</email>
    </contact>
    <investigator>
      <last_name>Jonathan B Bricker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04447313
org study id: RG1007177
secondary id: NCI-2020-01624
secondary id: 10404
secondary id: R01DK124114
nct id: NCT04447313
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase III trial compares telephone delivered Acceptance and Commitment Therapy to
      standard behavioral therapy for improving weight loss in overweight or obese participants.
      Acceptance and Commitment Therapy focuses on increasing willingness to experience physical
      cravings, emotions, and thoughts while making values-guided committed behavior changes.
      Acceptance and Commitment Therapy may work better at improving weight loss compared to
      standard behavioral therapy.
OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16
      weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration,
      while calls 2-25 are each 15-20 minutes in duration.

      ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16
      weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration,
      while calls 2-25 are each 15-20 minutes in duration.

      Participants are followed up at 6, 12, and 24 months after randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: 10% or more weight loss
time frame: At 12 months after randomization
description: Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.
measure: Percent weight change
time frame: At 6, 12, and 24-months post randomization
description: Will be measured remotely by cellular-enabled scales.
measure: Dietary intake
time frame: At 6, 12, and 24-months post randomization
description: Will be measured with the Fitbit smartphone app food logging feature.
measure: Physical activity
time frame: At 6, 12, and 24-months post randomization
description: Will be measured with the Fitbit Inspire mailed to participants.
measure: Trajectories of weight change
time frame: At 6, 12, and 24-months post randomization
description: Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.
arm group label: Arm I (ACT)
arm group type: Experimental
description: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
arm group label: Arm II (SBT)
arm group type: Active Comparator
description: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Arm I (ACT)
arm group label: Arm II (SBT)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive ACT telephone coaching
arm group label: Arm I (ACT)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive SBT telephone coaching
arm group label: Arm II (SBT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan B Bricker
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
last name: Brie Sullivan
phone: 206-667-5238
email: bsulliva@fredhutch.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Weight Loss
sharing ipd: No