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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03584191




Registration number
NCT03584191
Ethics application status
Date submitted
29/06/2018
Date registered
12/07/2018
Date last updated
24/05/2019

Titles & IDs
Public title
Awareness, Care & Treatment In Obesity Management - An International Observation
Scientific title
Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
Secondary ID [1] 0 0
U1111-1209-6406
Secondary ID [2] 0 0
NN8022-4449
Universal Trial Number (UTN)
Trial acronym
ACTION-IO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

People with Obesity - General population - potential participants will be recruited using various and numerous general population as appropriate in each country.

Health Care Professionals - Health Care Professionals include primary care physicians and specialists who treat patients with obesity.


Other interventions: No treatment given
Completion of a survey
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight loss motivators
Timepoint [1] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [2] 0 0
Proportion of PwO / patients who made serious weight loss effort
Timepoint [2] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [3] 0 0
Response to weight loss discussions
Timepoint [3] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [4] 0 0
Effective weight loss methods
Timepoint [4] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [5] 0 0
Obesity attitudes
Timepoint [5] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [6] 0 0
Attitudes toward prescription weight loss medication and surgery
Timepoint [6] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [7] 0 0
Weight loss barriers
Timepoint [7] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [8] 0 0
Obesity and weight management
Timepoint [8] 0 0
Start of interviews day 1 until end of data collection day 90
Primary outcome [9] 0 0
Degree to which healthcare and society is meeting needs of people with obesity
Timepoint [9] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [1] 0 0
Top factors for improving weight loss outcomes
Timepoint [1] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [2] 0 0
Types of weight management goals
Timepoint [2] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [3] 0 0
Most helpful information for patients for weight loss
Timepoint [3] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [4] 0 0
Responsibility for improving health of people with obesity
Timepoint [4] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [5] 0 0
Most helpful support for weight loss
Timepoint [5] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [6] 0 0
Effectiveness of guidelines for treating obesity
Timepoint [6] 0 0
Start of interviews day 1 until end of data collection day 90
Secondary outcome [7] 0 0
Ways you receive information on weight loss management
Timepoint [7] 0 0
Start of interviews day 1 until end of data collection day 90

Eligibility
Key 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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2018
Sample size
Target
Accrual to date
Final
17287
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Baulkham Hills
Recruitment postcode(s) [1] 0 0
2153 - Baulkham Hills
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Kfar Saba
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
Mexico
State/province [3] 0 0
Polanco
Country [4] 0 0
Saudi Arabia
State/province [4] 0 0
Riyadh
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
Switzerland
State/province [6] 0 0
Zürich
Country [7] 0 0
United Arab Emirates
State/province [7] 0 0
Dubai
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Gatwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03584191
Trial related presentations / publications
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.
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, 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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03584191