Awareness, Care & Treatment In Obesity Management - An International Observation

Obesity Clinical Trial

— ACTION-IO  

Official title:

Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584191
• Other study ID #: NN8022-4449
• Secondary ID: U1111-1209-6406
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Obesity

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