Clinical trial NCT03235102: Awareness, Care and Treatment in Obesity Management
Official title: Obesity ACTION Study in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 2545
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Awareness associated with the care and management of obesity among people with obesity, clinicians and employers
timeFrame: From the first interview on day 1 until the last interview on day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
Study officials:
References:
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.