ObesityACTION-IONCT03584191
Awareness, Care & Treatment In Obesity Management - An International Observation
An observational study of Obesity, run by Novo Nordisk A/S at 9 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- No treatment given
- How many people
- 17,287 participants
- Where
- 9 sitesin 9 countries
- Study dates
- 4 Jun 2018to 10 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with obesity and health care professionals
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
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Australia1 site
Novo Nordisk Investigational Site
Baulkham Hills, New South Wales, 2153
United Arab Emirates1 site
Novo Nordisk Investigational Site
Dubai
About this study
Official title: Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
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.
- Conditions
- Obesity
- Being tested
- No treatment given
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Completion of a survey
| Study group | Role | What they receive |
|---|---|---|
| People with Obesity | General population - potential participants will be recruited using various and numerous general population as appropriate in each country. Receives: Other: No treatment given | |
| Health Care Professionals | Health Care Professionals include primary care physicians and specialists who treat patients with obesity. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss motivators
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Proportion of PwO / patients who made serious weight loss effort
Online questionnaire - Numeric Response
Measured: Start of interviews day 1 until end of data collection day 90
Response to weight loss discussions
Online questionnaire - Single Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Effective weight loss methods
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Obesity attitudes
Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree)
Measured: Start of interviews day 1 until end of data collection day 90
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)
Measured: Start of interviews day 1 until end of data collection day 90
Weight loss barriers
Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
Measured: Start of interviews day 1 until end of data collection day 90
Obesity and weight management
Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
Measured: Start of interviews day 1 until end of data collection day 90
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)
Measured: Start of interviews day 1 until end of data collection day 90
Secondary outcomes (7)
Top factors for improving weight loss outcomes
Online questionnaire - Ranking Exercise
Measured: Start of interviews day 1 until end of data collection day 90
Types of weight management goals
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Most helpful information for patients for weight loss
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Responsibility for improving health of people with obesity
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Most helpful support for weight loss
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
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)
Measured: Start of interviews day 1 until end of data collection day 90
Ways you receive information on weight loss management
Online questionnaire - Multiple Item Selection
Measured: Start of interviews day 1 until end of data collection day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start4 Jun 2018
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 17,287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584191
- Sponsor's protocol ID
- NN8022-4449
- Other IDs
- U1111-1209-6406
- Acronym
- ACTION-IO
- Status last verified
- May 2019
- First submitted
- 29 Jun 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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.
PubMed 31032548Vilarrasa N, Salvador J, Poyato F, Rubio-Herrera MA. Does the Prevalence of Obesity in the Different Regions of Spain Influence the Attitudes, Perception, and Barriers to Its Treatment? Obes Facts. 2024;17(3):264-273. doi: 10.1159/000538257. Epub 2024 Mar 15.
PubMed 38493779Hughes 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.
PubMed 34193488Dicker 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.
PubMed 33558163Alfadda 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.
PubMed 33495083Vazquez-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.
PubMed 33491317Dicker 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.
PubMed 33087177Sbraccia 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.
PubMed 32385580
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
- ClinicalTrials.gov ID
- NCT03584191
- Acronym / sponsor ID
- ACTION-IO / NN8022-4449
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,287 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Obesity | – | Other: No treatment givenGeneral population - potential participants will be recruited using various and numerous general population as appropriate in each country. |
| Health Care Professionals | – | Other: No treatment givenHealth Care Professionals include primary care physicians and specialists who treat patients with obesity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with obesity and health care professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenCompletion of a survey | Other | Health Care Professionals, People with Obesity |
Primary outcome
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)
7 secondary outcomes
Top factors for improving weight loss outcomes
Time frame: Start of interviews day 1 until end of data collection day 90
Types of weight management goals
Time frame: Start of interviews day 1 until end of data collection day 90
Most helpful information for patients for weight loss
Time frame: Start of interviews day 1 until end of data collection day 90
Responsibility for improving health of people with obesity
Time frame: Start of interviews day 1 until end of data collection day 90
Most helpful support for weight loss
Time frame: Start of interviews day 1 until end of data collection day 90
Effectiveness of guidelines for treating obesity
Time frame: Start of interviews day 1 until end of data collection day 90
Ways you receive information on weight loss management
Time frame: Start of interviews day 1 until end of data collection day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Results publication: PubMed 31032548Caterson 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.
- Derived from this study: PubMed 38493779Vilarrasa N, Salvador J, Poyato F, Rubio-Herrera MA. Does the Prevalence of Obesity in the Different Regions of Spain Influence the Attitudes, Perception, and Barriers to Its Treatment? Obes Facts. 2024;17(3):264-273. doi: 10.1159/000538257. Epub 2024 Mar 15.
- Derived from this study: PubMed 34193488Hughes 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.
- Derived from this study: PubMed 33558163Dicker 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.
- Derived from this study: PubMed 33495083Alfadda 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.
- Derived from this study: PubMed 33491317Vazquez-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.
- Derived from this study: PubMed 33087177Dicker 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.
- Derived from this study: PubMed 32385580Sbraccia 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, Israel, Mexico, Saudi Arabia, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss motivators (time frame: Start of interviews day 1 until end of data collection day 90). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584191, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.