Awareness, Care and Treatment in Obesity Management

Obesity Clinical Trial

Official title:

Obesity ACTION Study in Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235102
• Other study ID #: INS-4411
• Secondary ID: U1111-1199-1902
• Status: Completed
• Start date: August 3, 2017
• Est. completion date: October 11, 2017

Study information

• Verified date: July 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2545
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Other:
• No treatment given
Completion of a survey

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Sharma AM, Bélanger 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. Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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