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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584191
Other study ID # NN8022-4449
Secondary ID U1111-1209-6406
Status Completed
Phase
First received
Last updated
Start date June 4, 2018
Est. completion date October 10, 2018

Study information

Verified date May 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this survey is to collect the data on perceptions, behaviours and awareness related to obesity and obesity management for People with Obesity (PwO) and Health Care Professionals (HCP) treating obesity. Data will be collected via online surveys among each of the respondent groups. The surveys are expected to take approximately 25 minutes to complete and will be unique for PwO and HCP. As a cross-sectional study, there will be no treatment of patients.


Recruitment information / eligibility

Status Completed
Enrollment 17287
Est. completion date October 10, 2018
Est. primary completion date October 10, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - PEOPLE WITH OBESITY - Age at least 18 years, both males and females - On-line consent to participate in study - Lives in one of the participating countries: Italy, Spain, United Kingdom (UK), Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, United Arab Emirates (UAE), Japan, South Korea - Current Body Mass Index (BMI) (based on self-reported height and weight) greater than or equal to 30 kg/sqm in Italy, Spain, UK, Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, UAE; current BMI greater than or equal to 25 kg/sqm in Japan and South Korea - HEALTH CARE PROFESSIONALS - Physician - Specialty is NOT plastic surgeon, general surgeon, or bariatric surgeon - Practices in one of the participating countries: Italy, Spain, UK, Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, UAE, Japan, South Korea - In practice at least 2 years - Spends at least 70 percent of time in direct patient care - Has seen at least 100 patients in past month - Has seen at least 10 patients in past month needing weight management defined as: a patient with a BMI greater than or equal to 30 kg/sqm with or without comorbidities. (BMI greater than or equal to 25 kg/sqm in Japan and South Korea) Exclusion Criteria: - PEOPLE WITH OBESITY - Declines to provide income - Previous participation in this study. Participation is defined as having given online consent in this study - Declines to provide race / ethnicity (in applicable countries) - Currently pregnant - Participates in intense fitness or body building programs - Has had significant, unintentional weight loss (due to major injury, illness, etc.) in the past 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No treatment given
Completion of a survey

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Baulkham Hills New South Wales
Israel Novo Nordisk Investigational Site Kfar Saba
Korea, Republic of Novo Nordisk Investigational Site Seoul
Mexico Novo Nordisk Investigational Site Polanco
Saudi Arabia Novo Nordisk Investigational Site Riyadh
Spain Novo Nordisk Investigational Site Madrid
Switzerland Novo Nordisk Investigational Site Zürich
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Kingdom Novo Nordisk Investigational Site Gatwick

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Israel,  Korea, Republic of,  Mexico,  Saudi Arabia,  Spain,  Switzerland,  United Arab Emirates,  United Kingdom, 

References & Publications (1)

Caterson ID, Alfadda AA, Auerbach P, Coutinho W, Cuevas A, Dicker D, Hughes C, Iwabu M, Kang JH, Nawar R, Reynoso R, Rhee N, Rigas G, Salvador J, Sbraccia P, Vázquez-Velázquez V, Halford JCG. Gaps to bridge: Misalignment between perception, reality and ac — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss motivators Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Primary Proportion of PwO / patients who made serious weight loss effort Online questionnaire - Numeric Response Start of interviews day 1 until end of data collection day 90
Primary Response to weight loss discussions Online questionnaire - Single Item Selection Start of interviews day 1 until end of data collection day 90
Primary Effective weight loss methods Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Primary Obesity attitudes Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Primary Attitudes toward prescription weight loss medication and surgery Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Primary Weight loss barriers Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Primary Obesity and weight management Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Primary Degree to which healthcare and society is meeting needs of people with obesity Online questionnaire - End-anchored 5-point Likert needs scale(from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Secondary Top factors for improving weight loss outcomes Online questionnaire - Ranking Exercise Start of interviews day 1 until end of data collection day 90
Secondary Types of weight management goals Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Secondary Most helpful information for patients for weight loss Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Secondary Responsibility for improving health of people with obesity Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Secondary Most helpful support for weight loss Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
Secondary Effectiveness of guidelines for treating obesity Online questionnaire - Fully-anchored 5-point Likert scale (from "1", do not agree at all, to "5" completely agree) Start of interviews day 1 until end of data collection day 90
Secondary Ways you receive information on weight loss management Online questionnaire - Multiple Item Selection Start of interviews day 1 until end of data collection day 90
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