Awareness, Care and Treatment in Obesity Management

Obesity ACTION Study in Canada

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 2545

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.	Other: 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.	Other: 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.	Other: No treatment given; Completion of a survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness associated with the care and management of obesity among people with obesity, clinicians and employers	Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)	From the first interview on day 1 until the last interview on day 30

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): October 11, 2017
• Study Completion (Actual): October 11, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Overweight; Body Weight; Obesity; Nutrition Disorders
• Other Study ID Numbers: INS-4411; U1111-1199-1902 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No