Awareness, Care and Treatment in Obesity Management

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03235102
Collaborator
(none)
2,545
1
2.3
1122.7

Study Details

Study Description

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 Phase
  • Other: No treatment given

Study Design

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 :
Aug 3, 2017
Actual Primary Completion Date :
Oct 11, 2017
Actual Study Completion Date :
Oct 11, 2017

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Awareness associated with the care and management of obesity among people with obesity, clinicians and employers [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Edmonton Alberta Canada T6G 2E1

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03235102
Other Study ID Numbers:
  • INS-4411
  • U1111-1199-1902
First Posted:
Aug 1, 2017
Last Update Posted:
Jul 19, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2019