<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/NCT03801174</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1400</org_study_id>
    <secondary_id>1R01DK111491-01A1</secondary_id>
    <secondary_id>A539722</secondary_id>
    <secondary_id>SMPH/SURGERY</secondary_id>
    <secondary_id>2018-1400-CP028</secondary_id>
    <nct_id>NCT03801174</nct_id>
  </id_info>
  <brief_title>Using Partners to Enhance Long-Term Weight Loss</brief_title>
  <acronym>Partner2Lose</acronym>
  <official_title>Using Partners to Enhance Long-Term Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</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 study involves an evaluation of the role of domestic partner support in a comprehensive&#xD;
      weight loss initiation and maintenance program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Couples will be randomized to a comprehensive weight program directed at patients alone or&#xD;
      involving their partners. In months 1-6, all patients will receive group-based weight loss&#xD;
      program. In months 7-18, all patients will receive a telephone-based weight loss maintenance&#xD;
      intervention. In the partner-assisted arm only, partners will participate in the&#xD;
      intervention, learning and practicing communication skills and support strategies. In months&#xD;
      19-24, intervention will be withdrawn to examine sustainability of effects.&#xD;
&#xD;
      Due to COVID-19, option of doing screening and outcome assessment visits and attending the&#xD;
      group classes (including exercise) remotely via a video conference may be available. COVID-19&#xD;
      survey will be administered every 3 month starting at screening/enrollment visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">March 20, 2023</completion_date>
  <primary_completion_date type="Actual">March 14, 2023</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>Body weight (kg)</measure>
    <time_frame>24 months</time_frame>
    <description>Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caloric intake (kcal)</measure>
    <time_frame>24 months</time_frame>
    <description>average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>24 months</time_frame>
    <description>average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Transformation of motivation for diet</measure>
    <time_frame>3 months</time_frame>
    <description>Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome efficacy for diet</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)</description>
  </other_outcome>
  <other_outcome>
    <measure>Couple efficacy for diet</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support for diet</measure>
    <time_frame>3 months</time_frame>
    <description>9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of communal coping strategies for diet</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)</description>
  </other_outcome>
  <other_outcome>
    <measure>Transformation of motivation for physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome efficacy for physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)</description>
  </other_outcome>
  <other_outcome>
    <measure>Couple efficacy for physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support for physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of communal coping strategies for physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">462</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Partner-assisted intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and partners will receive intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient-only intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partner-assisted intervention</intervention_name>
    <description>All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.</description>
    <arm_group_label>Partner-assisted intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient-only intervention</intervention_name>
    <description>All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.</description>
    <arm_group_label>Patient-only intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (patients):&#xD;
&#xD;
          -  Aged 18-74 years&#xD;
&#xD;
          -  BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI &gt;=30 kg/m2&#xD;
&#xD;
          -  Cohabitating and at least daily contact with a spouse/domestic partner&#xD;
&#xD;
          -  Access to reliable transportation&#xD;
&#xD;
          -  Desire to lose weight&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
          -  Agree to attend visits per protocol&#xD;
&#xD;
          -  Score of at least 4 out of 6 on Callahan cognitive screener&#xD;
&#xD;
          -  Able to stand without assistance for weight measurements without assistance&#xD;
&#xD;
          -  Possess individual email address&#xD;
&#xD;
          -  Possess individual smart phone with data and texting plan&#xD;
&#xD;
          -  Able to complete online screener without assistance&#xD;
&#xD;
          -  Able to use a smartphone, tablet or computer with a video camera or webcam and&#xD;
             microphone to download apps and to connect to a video conference call without&#xD;
             assistance&#xD;
&#xD;
        Exclusion Criteria (patients):&#xD;
&#xD;
          -  Currently or planning to become pregnant or breastfeeding in the study timeframe&#xD;
&#xD;
          -  Weight loss ≥ 5 lb in the month prior to screening&#xD;
&#xD;
          -  Currently enrolled, or enrolled in previous 3 months, in a clinical or research&#xD;
             program focusing on lifestyle change that could affect weight&#xD;
&#xD;
          -  Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse&#xD;
&#xD;
          -  Chronic or unstable illness that would limit ability to participate (e.g., recent&#xD;
             hospitalization; unstable heart disease in the 6 months prior to screening, chronic&#xD;
             kidney disease stage 4 or higher)&#xD;
&#xD;
          -  Living a nursing home or receiving visits from a home health care agency&#xD;
&#xD;
          -  Planning to relocate in the next 2.5 years&#xD;
&#xD;
          -  Current use of prescription or over-the-counter weight loss medications&#xD;
&#xD;
          -  History of bariatric surgery or planning to have bariatric surgery in the study&#xD;
             timeframe&#xD;
&#xD;
          -  Impaired hearing&#xD;
&#xD;
          -  Currently receiving, or received in the past 6 months, treatment for cancer other than&#xD;
             skin cancer&#xD;
&#xD;
          -  Use of insulin, sulfonylureas, or meglinitides for diabetes&#xD;
&#xD;
          -  High diuretic dose&#xD;
&#xD;
          -  Exertional chest pain, dizziness, or lightheadedness&#xD;
&#xD;
          -  Pain or other condition than prohibits mild-moderate exercise&#xD;
&#xD;
          -  History of ascites requiring paracentesis&#xD;
&#xD;
        Inclusion criteria (partner):&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Access to reliable transportation&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
          -  Score of at least 4 out of 6 on Callahan cognitive screener&#xD;
&#xD;
          -  Possess smart phone with data and texting plan (not shared with index patient)&#xD;
&#xD;
          -  Possess email address (not shared with index patient)&#xD;
&#xD;
          -  Able to complete online screener without assistance&#xD;
&#xD;
        Exclusion criteria (partner):&#xD;
&#xD;
          -  BMI &lt;18.5 kg/m2&#xD;
&#xD;
          -  Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse&#xD;
&#xD;
          -  Residing in a nursing home or receiving home health care&#xD;
&#xD;
          -  Impaired hearing&#xD;
&#xD;
          -  Currently receiving, or received in the past 6 months, treatment for cancer other than&#xD;
             skin cancer&#xD;
&#xD;
          -  Chronic or unstable illness that would limit ability to participate (e.g., recent&#xD;
             hospitalization; unstable heart disease in the 6 months prior to screening)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corrine Voils, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.partner2lose.com</url>
    <description>Partner2Lose website</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03801174/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03801174
org study id: 2018-1400
secondary id: 1R01DK111491-01A1
secondary id: A539722
secondary id: SMPH/SURGERY
secondary id: 2018-1400-CP028
nct id: NCT03801174
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study involves an evaluation of the role of domestic partner support in a comprehensive
      weight loss initiation and maintenance program.
Couples will be randomized to a comprehensive weight program directed at patients alone or
      involving their partners. In months 1-6, all patients will receive group-based weight loss
      program. In months 7-18, all patients will receive a telephone-based weight loss maintenance
      intervention. In the partner-assisted arm only, partners will participate in the
      intervention, learning and practicing communication skills and support strategies. In months
      19-24, intervention will be withdrawn to examine sustainability of effects.

      Due to COVID-19, option of doing screening and outcome assessment visits and attending the
      group classes (including exercise) remotely via a video conference may be available. COVID-19
      survey will be administered every 3 month starting at screening/enrollment visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Body weight (kg)
time frame: 24 months
description: Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
measure: Caloric intake (kcal)
time frame: 24 months
description: average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
measure: Physical activity
time frame: 24 months
description: average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
measure: Transformation of motivation for diet
time frame: 3 months
description: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
measure: Outcome efficacy for diet
time frame: 3 months
description: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
measure: Couple efficacy for diet
time frame: 3 months
description: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
measure: Social support for diet
time frame: 3 months
description: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
measure: Use of communal coping strategies for diet
time frame: 3 months
description: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
measure: Transformation of motivation for physical activity
time frame: 3 months
description: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
measure: Outcome efficacy for physical activity
time frame: 3 months
description: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
measure: Couple efficacy for physical activity
time frame: 3 months
description: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
measure: Social support for physical activity
time frame: 3 months
description: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
measure: Use of communal coping strategies for physical activity
time frame: 3 months
description: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
arm group label: Partner-assisted intervention
arm group type: Experimental
description: Patients and partners will receive intervention
arm group label: Patient-only intervention
arm group type: Active Comparator
description: Patients will receive intervention
intervention type: Behavioral
intervention name: Partner-assisted intervention
description: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
arm group label: Partner-assisted intervention
intervention type: Behavioral
intervention name: Patient-only intervention
description: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
arm group label: Patient-only intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Corrine Voils, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: http://www.partner2lose.com
description: Partner2Lose website
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No
provided document: 