Clinical trial NCT03584191: Awareness, Care & Treatment In Obesity Management - An International Observation
Official title: Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-07-12
Enrollment: 17287
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity and health care professionals

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.


Eligibility 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

Primary outcomes:
measure: Weight loss motivators
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Proportion of PwO / patients who made serious weight loss effort
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Response to weight loss discussions
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Effective weight loss methods
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Obesity attitudes
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Attitudes toward prescription weight loss medication and surgery
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Weight loss barriers
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Obesity and weight management
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Degree to which healthcare and society is meeting needs of people with obesity
timeFrame: Start of interviews day 1 until end of data collection day 90
Secondary outcomes:
measure: Top factors for improving weight loss outcomes
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Types of weight management goals
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Most helpful information for patients for weight loss
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Responsibility for improving health of people with obesity
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Most helpful support for weight loss
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Effectiveness of guidelines for treating obesity
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Ways you receive information on weight loss management
timeFrame: Start of interviews day 1 until end of data collection day 90
Other outcomes:
Locations:
city: Baulkham Hills
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Polanco
country: Mexico
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Gatwick
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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, Vazquez-Velazquez 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.
citation: 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.
citation: 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, Vazquez-Velazquez 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.
citation: 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, Vazquez-Velazquez 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.
citation: Vazquez-Velazquez V, Laviada-Molina H, Garcia-Garcia 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.
citation: 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.
citation: 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.