<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/NCT03235102</url>
  </required_header>
  <id_info>
    <org_study_id>INS-4411</org_study_id>
    <secondary_id>U1111-1199-1902</secondary_id>
    <nct_id>NCT03235102</nct_id>
  </id_info>
  <brief_title>Awareness, Care and Treatment in Obesity Management</brief_title>
  <official_title>Obesity ACTION Study in Canada</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</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 study aims to assess barriers that prevent obesity patients from receiving adequate care&#xD;
      for their condition. The non-interventional study will be administered in the form of a&#xD;
      30-minute, cross-sectional, online survey to various respondents. There is no experimentation&#xD;
      involved in the process of data collection, and each survey poses minimal human risk.&#xD;
&#xD;
      The study will evaluate lifestyle habits and weight management strategies perceived and/or&#xD;
      practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers,&#xD;
      and Employers. A customized survey will be administered to each of the 3 stakeholders, and&#xD;
      data will be analyzed based on respondents' answers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">October 11, 2017</completion_date>
  <primary_completion_date type="Actual">October 11, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Awareness associated with the care and management of obesity among people with obesity, clinicians and employers</measure>
    <time_frame>From the first interview on day 1 until the last interview on day 30</time_frame>
    <description>Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2545</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>People with Obesity</arm_group_label>
    <description>People with obesity, or weight loss patients. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthcare Providers</arm_group_label>
    <description>PCPs will include family practitioners; general practitioners; internal medicine; nurse practitioners; and dietitians. Specialists will include endocrinologists and bariatric surgeons, and any of the above if they focus on obesity treatment. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Employers</arm_group_label>
    <description>Employers in Canada. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment given</intervention_name>
    <description>Completion of a survey</description>
    <arm_group_label>Employers</arm_group_label>
    <arm_group_label>Healthcare Providers</arm_group_label>
    <arm_group_label>People with Obesity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All respondents will be recruited from the OMR Globus healthcare panel&#xD;
        (http://www.omrglobus.com/). The OMR Globus panel is an opt-in panel, in which respondents&#xD;
        join with the understanding they would complete periodic surveys. Members of this panel are&#xD;
        not associated with any specific site or organization. Recruitment of these respondents is&#xD;
        based on voluntary participation; invitations are sent to the personal e-mail accounts of&#xD;
        each respondent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        The following inclusion criteria will be imposed for HCPs:&#xD;
&#xD;
          -  Practice in Canada&#xD;
&#xD;
          -  Spends at least 70% of time in direct patient care&#xD;
&#xD;
          -  Seen at least 100 patients in past month&#xD;
&#xD;
          -  Seen at least 10 patients in past month needing weight management&#xD;
&#xD;
          -  In practice 2-35 years&#xD;
&#xD;
          -  Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms&#xD;
&#xD;
          -  PCP - Physician, RN / NP / LPN, or PA, Dietitians&#xD;
&#xD;
          -  PCP - Specialty is FP, IM, GP&#xD;
&#xD;
          -  Obesity Specialist - Physician, RN / NP / LPN, or PA&#xD;
&#xD;
          -  Obesity Specialist - Specialty is FP, IM, GP, endocrinology, bariatrics, or bariatric&#xD;
             surgery&#xD;
&#xD;
          -  Obesity Specialist - Currently practice as an obesity medicine or weight loss&#xD;
             management specialist&#xD;
&#xD;
        The following inclusion criteria will be imposed for PwOs (people with obesity):&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Lives in Canada&#xD;
&#xD;
          -  Recruitment will target a nationally representative Canada sample. Demographic&#xD;
             indicators will be monitored throughout recruitment.&#xD;
&#xD;
          -  Current BMI 30 kg/sqm or greater, not extremely fit/body building&#xD;
&#xD;
          -  Sub-category - Maintaining weight loss: Lost at least 10% of body weight in the past 3&#xD;
             years and has kept weight off for at least a year&#xD;
&#xD;
          -  Sub-category - Treatment Seeking: Has committed to a plan to lose weight, or has&#xD;
             successfully lost weight (self-report) or has spoken to an HCP about weight loss plan&#xD;
             in the last 6 months.&#xD;
&#xD;
        The following inclusion criteria will be imposed for employers:&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Works in a Canadian province&#xD;
&#xD;
          -  Company offers health insurance&#xD;
&#xD;
          -  Responsible for making or influencing decisions about health insurance or health and&#xD;
             wellness programs&#xD;
&#xD;
          -  Works in a company that has 20 or more employees&#xD;
&#xD;
          -  Believes there is a weight issue (attitudinal agreement)&#xD;
&#xD;
          -  Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms&#xD;
&#xD;
        Exclusion criteria Any respondent who work works for a pharmaceutical, health insurance,&#xD;
        research, or advertising company will be excluded; as there may be self-presentation&#xD;
        effects that could alter the interview questions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Sharma AM, Belanger A, Carson V, Krah J, Langlois MF, Lawlor D, Lepage S, Liu A, Macklin DA, MacKay N, Pakseresht A, Pedersen SD, Ramos Salas X, Vallis M. Perceptions of barriers to effective obesity management in Canada: Results from the ACTION study. Clin Obes. 2019 Oct;9(5):e12329. doi: 10.1111/cob.12329. Epub 2019 Jul 11.</citation>
    <PMID>31294535</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2019</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>Obesity</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
  </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/NCT03235102
org study id: INS-4411
secondary id: U1111-1199-1902
nct id: NCT03235102
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess barriers that prevent obesity patients from receiving adequate care
      for their condition. The non-interventional study will be administered in the form of a
      30-minute, cross-sectional, online survey to various respondents. There is no experimentation
      involved in the process of data collection, and each survey poses minimal human risk.

      The study will evaluate lifestyle habits and weight management strategies perceived and/or
      practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers,
      and Employers. A customized survey will be administered to each of the 3 stakeholders, and
      data will be analyzed based on respondents' answers.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Awareness associated with the care and management of obesity among people with obesity, clinicians and employers
time frame: From the first interview on day 1 until the last interview on day 30
description: Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)
arm group label: People with Obesity
description: People with obesity, or weight loss patients. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.
arm group label: Healthcare Providers
description: PCPs will include family practitioners; general practitioners; internal medicine; nurse practitioners; and dietitians. Specialists will include endocrinologists and bariatric surgeons, and any of the above if they focus on obesity treatment. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.
arm group label: Employers
description: Employers in Canada. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.
intervention type: Other
intervention name: No treatment given
description: Completion of a survey
arm group label: Employers
arm group label: Healthcare Providers
arm group label: People with Obesity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
citation: Sharma AM, Belanger A, Carson V, Krah J, Langlois MF, Lawlor D, Lepage S, Liu A, Macklin DA, MacKay N, Pakseresht A, Pedersen SD, Ramos Salas X, Vallis M. Perceptions of barriers to effective obesity management in Canada: Results from the ACTION study. Clin Obes. 2019 Oct;9(5):e12329. doi: 10.1111/cob.12329. Epub 2019 Jul 11.
PMID: 31294535
responsible party type: Sponsor
mesh term: Obesity
mesh term: Nutrition Disorders
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com