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Awareness, Care and Treatment in Obesity Management

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ClinicalTrials.gov Identifier: NCT03235102
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

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.


Condition or disease Intervention/treatment
Metabolism and Nutrition Disorder Obesity Behavioral: No treatment given

Study Type : Observational
Actual Enrollment : 2545 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Obesity ACTION Study in Canada
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : October 11, 2017

Group/Cohort Intervention/treatment
People with Obesity
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.
Behavioral: No treatment given
Completion of a survey

Healthcare Providers
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.
Behavioral: No treatment given
Completion of a survey

Employers
Employers in Canada. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey.
Behavioral: No treatment given
Completion of a survey




Primary Outcome Measures :
  1. 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 ]
    Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All respondents will be recruited from the OMR Globus healthcare panel (http://www.omrglobus.com/). The OMR Globus panel is an opt-in panel, in which respondents join with the understanding they would complete periodic surveys. Members of this panel are not associated with any specific site or organization. Recruitment of these respondents is based on voluntary participation; invitations are sent to the personal e-mail accounts of each respondent.
Criteria

Inclusion criteria

The following inclusion criteria will be imposed for HCPs:

  • Practice in Canada
  • Spends at least 70% of time in direct patient care
  • Seen at least 100 patients in past month
  • Seen at least 10 patients in past month needing weight management
  • In practice 2-35 years
  • Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms
  • PCP - Physician, RN / NP / LPN, or PA, Dietitians
  • PCP - Specialty is FP, IM, GP
  • Obesity Specialist - Physician, RN / NP / LPN, or PA
  • Obesity Specialist - Specialty is FP, IM, GP, endocrinology, bariatrics, or bariatric surgery
  • Obesity Specialist - Currently practice as an obesity medicine or weight loss management specialist

The following inclusion criteria will be imposed for PwOs (people with obesity):

  • Age at least 18 years
  • Lives in Canada
  • Recruitment will target a nationally representative Canada sample. Demographic indicators will be monitored throughout recruitment.
  • Current BMI 30 kg/sqm or greater, not extremely fit/body building
  • Sub-category - Maintaining weight loss: Lost at least 10% of body weight in the past 3 years and has kept weight off for at least a year
  • Sub-category - Treatment Seeking: Has committed to a plan to lose weight, or has successfully lost weight (self-report) or has spoken to an HCP about weight loss plan in the last 6 months.

The following inclusion criteria will be imposed for employers:

  • Age at least 18 years
  • Works in a Canadian province
  • Company offers health insurance
  • Responsible for making or influencing decisions about health insurance or health and wellness programs
  • Works in a company that has 20 or more employees
  • Believes there is a weight issue (attitudinal agreement)
  • Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms

Exclusion criteria Any respondent who work works for a pharmaceutical, health insurance, research, or advertising company will be excluded; as there may be self-presentation effects that could alter the interview questions.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235102


Locations
Canada, Alberta
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03235102     History of Changes
Other Study ID Numbers: INS-4411
U1111-1199-1902 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Nutrition Disorders
Overnutrition
Overweight
Body Weight
Signs and Symptoms