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

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ClinicalTrials.gov Identifier: NCT03584191

Recruitment Status : Completed

First Posted : July 12, 2018

Last Update Posted : May 24, 2019

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Obesity	Other: No treatment given

Study Design

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Study Type :	Observational
Actual Enrollment :	17287 participants
Observational Model:	Ecologic or Community
Time Perspective:	Cross-Sectional
Official Title:	Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
Actual Study Start Date :	June 4, 2018
Actual Primary Completion Date :	October 10, 2018
Actual Study Completion Date :	October 10, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
People with Obesity General population - potential participants will be recruited using various and numerous general population as appropriate in each country.	Other: No treatment given Completion of a survey
Health Care Professionals Health Care Professionals include primary care physicians and specialists who treat patients with obesity.	Other: No treatment given Completion of a survey

Outcome Measures

Primary Outcome Measures :

Weight loss motivators [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Proportion of PwO / patients who made serious weight loss effort [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Numeric Response
Response to weight loss discussions [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Single Item Selection
Effective weight loss methods [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Obesity attitudes [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree)
Attitudes toward prescription weight loss medication and surgery [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree)
Weight loss barriers [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
Obesity and weight management [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
Degree to which healthcare and society is meeting needs of people with obesity [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - End-anchored 5-point Likert needs scale(from "1", do not agree at all, to "5" completely agree)

Secondary Outcome Measures :

Top factors for improving weight loss outcomes [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Ranking Exercise
Types of weight management goals [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Most helpful information for patients for weight loss [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Responsibility for improving health of people with obesity [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Most helpful support for weight loss [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection
Effectiveness of guidelines for treating obesity [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Fully-anchored 5-point Likert scale (from "1", do not agree at all, to "5" completely agree)
Ways you receive information on weight loss management [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
Online questionnaire - Multiple Item Selection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with obesity and health care professionals

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584191

Locations

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Australia, New South Wales
Novo Nordisk Investigational Site
Baulkham Hills, New South Wales, Australia, 2153
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of
Mexico
Novo Nordisk Investigational Site
Polanco, Mexico
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland
United Arab Emirates
Novo Nordisk Investigational Site
Dubai, United Arab Emirates
United Kingdom
Novo Nordisk Investigational Site
Gatwick, United Kingdom

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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Study Director:	Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S

More Information

Publications of Results:

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 actions in obesity. Diabetes Obes Metab. 2019 Aug;21(8):1914-1924. doi: 10.1111/dom.13752. Epub 2019 May 3.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hughes CA, Ahern AL, Kasetty H, McGowan BM, Parretti HM, Vincent A, Halford JCG. Changing the narrative around obesity in the UK: a survey of people with obesity and healthcare professionals from the ACTION-IO study. BMJ Open. 2021 Jun 30;11(6):e045616. doi: 10.1136/bmjopen-2020-045616.

Dicker D, Alfadda AA, Coutinho W, Cuevas A, Halford JCG, Hughes CA, Iwabu M, Kang JH, Nawar R, Reynoso R, Rhee N, Rigas G, Salvador J, Sbraccia P, Vázquez-Velázquez V, Caterson ID. Patient motivation to lose weight: Importance of healthcare professional support, goals and self-efficacy. Eur J Intern Med. 2021 Sep;91:10-16. doi: 10.1016/j.ejim.2021.01.019. Epub 2021 Feb 6.

Alfadda AA, Caterson ID, Coutinho W, Cuevas A, Dicker D, Halford JCG, Hughes CA, Iwabu M, Kang JH, Nawar R, Reynoso R, Rhee N, Rigas G, Salvador J, Vázquez-Velázquez V, Sbraccia P. The 3Ds - Discussion, diagnosis and direction: Elements for effective obesity care by healthcare professionals. Eur J Intern Med. 2021 Sep;91:17-25. doi: 10.1016/j.ejim.2021.01.012. Epub 2021 Jan 23.

Vázquez-Velázquez V, Laviada-Molina H, García-García E, Sandoval-Diez E, Mancillas-Adame L. Perceptions, Attitudes, and Barriers to Obesity Care in Mexico: Data From the ACTION-IO Study. Obesity (Silver Spring). 2021 Feb;29(2):317-326. doi: 10.1002/oby.23077.

Dicker D, Kornboim B, Bachrach R, Shehadeh N, Potesman-Yona S, Segal-Lieberman G. ACTION-IO as a platform to understand differences in perceptions, attitudes, and behaviors of people with obesity and physicians across countries - the Israeli experience. Isr J Health Policy Res. 2020 Oct 21;9(1):56. doi: 10.1186/s13584-020-00404-2.

Sbraccia P, Busetto L, Santini F, Mancuso M, Nicoziani P, Nicolucci A. Misperceptions and barriers to obesity management: Italian data from the ACTION-IO study. Eat Weight Disord. 2021 Apr;26(3):817-828. doi: 10.1007/s40519-020-00907-6. Epub 2020 May 8.

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Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT03584191
Other Study ID Numbers:	NN8022-4449 U1111-1209-6406 ( Other Identifier: World Health Organization (WHO) )
First Posted:	July 12, 2018 Key Record Dates
Last Update Posted:	May 24, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL:	http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Obesity Overnutrition Nutrition Disorders Overweight Body Weight

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