<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/NCT04433806</url>
  </required_header>
  <id_info>
    <org_study_id>19-010206</org_study_id>
    <nct_id>NCT04433806</nct_id>
  </id_info>
  <brief_title>Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity</brief_title>
  <official_title>The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The purposes of this study is to evaluate the feasibility of providing a community based&#xD;
      referral to Mayo Clinic Employee and Community Health patients for weight loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants recruited</measure>
    <time_frame>Through study completion, approximately 28 weeks</time_frame>
    <description>Total number of participants recruited</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants enrolled</measure>
    <time_frame>Through study completion, approximately 28 weeks</time_frame>
    <description>Total number of participants enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants accrued</measure>
    <time_frame>Through study completion, approximately 28 weeks</time_frame>
    <description>Total number of participants accrued</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants to withdrawn or terminate study participation</measure>
    <time_frame>Through study completion, approximately 28 weeks</time_frame>
    <description>Total number of participants to withdrawn or terminate study participation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction</measure>
    <time_frame>At study completion, approximately 28 weeks</time_frame>
    <description>Measured using the self-reported Was It Worth It (WIWI) Questionnaire that uses a total of 13 questions that asks feedback on participants experience and satisfaction with the Mayo Clinic/ExercisAbilities weight loss program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff satisfaction</measure>
    <time_frame>At study completion, approximately 28 weeks</time_frame>
    <description>Measured using the self-reported ExercisAbilities Staff Survey (Post-Intervention) that uses a total of 3 questions to rate experience on a scale of very satisfied to extremely not satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Baseline, week 16, week 28</time_frame>
    <description>Change in participant's weight measure in kilograms (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Baseline, week 16, week 28</time_frame>
    <description>Change in participant's BMI calculated by weight in kilograms divided by the square of height in meters (kg/m2)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Obesity</condition>
  <condition>Lifestyle, Healthy</condition>
  <condition>Community Based Programs</condition>
  <condition>Primary Care Referrals</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 subjects, all referred to community based program for weight loss at ExercisAbilities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral to weight loss program</intervention_name>
    <description>16 weeks Diabetes Prevention Program based weight loss program at a local community partner</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are between 18-65 years of age&#xD;
&#xD;
          -  Patients who have a BMI between 25-39.9 kg/m2&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Ability to complete the Diabetes Prevention Program including dietary and physical&#xD;
             activity recommendations&#xD;
&#xD;
          -  Motivated to lose weight (assessed to be in the preparation or action stage)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have used weight loss medications or participated in a weight loss program within the&#xD;
             past 30 days.&#xD;
&#xD;
          -  Are currently enrolled in DPP or other ExercisAbilities weight loss programs&#xD;
&#xD;
          -  Are currently taking supplements known to affect weight.&#xD;
&#xD;
          -  Have had weight fluctuations of 20 pounds or more in the past 6 months (EMR check and&#xD;
             self-report)&#xD;
&#xD;
          -  Have an active untreated clinically significant psychiatric condition (psychosis,&#xD;
             bipolar disorder, or depression)&#xD;
&#xD;
          -  Are currently pregnant or breastfeeding, or are of child-bearing potential and are&#xD;
             likely to become pregnant during the study (within the next 4 months following&#xD;
             enrollment)&#xD;
&#xD;
          -  Have a history in the past 4 months of any major cardiovascular events including heart&#xD;
             valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome,&#xD;
             stroke, transient ischemic attack, or peripheral vascular disease&#xD;
&#xD;
          -  Have current uncontrolled hypertension (systolic &gt; 160 mm Hg or diastolic &gt; 95 mm Hg)&#xD;
             documented on 2 separate occasions&#xD;
&#xD;
          -  Have clinically significant acute or chronic progressive or unstable neurologic,&#xD;
             hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as&#xD;
             diabetes) or active cancer or are within 1 year of cancer remission&#xD;
&#xD;
          -  Have a known history of any condition or factor judged by the investigator/study team&#xD;
             to preclude participation in the study or which might hinder adherence&#xD;
&#xD;
          -  Have any co-morbidity that is deemed exclusionary at the discretion of the provider.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamim Rajjo, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Tamim I. Rajjo, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT04433806
org study id: 19-010206
nct id: NCT04433806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purposes of this study is to evaluate the feasibility of providing a community based
      referral to Mayo Clinic Employee and Community Health patients for weight loss.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Participants recruited
time frame: Through study completion, approximately 28 weeks
description: Total number of participants recruited
measure: Participants enrolled
time frame: Through study completion, approximately 28 weeks
description: Total number of participants enrolled
measure: Participants accrued
time frame: Through study completion, approximately 28 weeks
description: Total number of participants accrued
measure: Participants to withdrawn or terminate study participation
time frame: Through study completion, approximately 28 weeks
description: Total number of participants to withdrawn or terminate study participation
measure: Participant satisfaction
time frame: At study completion, approximately 28 weeks
description: Measured using the self-reported Was It Worth It (WIWI) Questionnaire that uses a total of 13 questions that asks feedback on participants experience and satisfaction with the Mayo Clinic/ExercisAbilities weight loss program.
measure: Staff satisfaction
time frame: At study completion, approximately 28 weeks
description: Measured using the self-reported ExercisAbilities Staff Survey (Post-Intervention) that uses a total of 3 questions to rate experience on a scale of very satisfied to extremely not satisfied.
measure: Change in weight
time frame: Baseline, week 16, week 28
description: Change in participant's weight measure in kilograms (kg)
measure: Change in Body Mass Index (BMI)
time frame: Baseline, week 16, week 28
description: Change in participant's BMI calculated by weight in kilograms divided by the square of height in meters (kg/m2)
arm group label: Intervention
arm group type: Experimental
description: 25 subjects, all referred to community based program for weight loss at ExercisAbilities
intervention type: Behavioral
intervention name: Referral to weight loss program
description: 16 weeks Diabetes Prevention Program based weight loss program at a local community partner
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tamim Rajjo, MD, MPH
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Tamim I. Rajjo, M.D.
investigator title: Principal Investigator
mesh term: Obesity