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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 17287

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity and health care professionals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss motivators	Online questionnaire - Multiple Item Selection	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	Start of interviews day 1 until end of data collection day 90
Response to weight loss discussions	Online questionnaire - Single Item Selection	Start of interviews day 1 until end of data collection day 90
Effective weight loss methods	Online questionnaire - Multiple Item Selection	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)	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)	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)	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)	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)	Start of interviews day 1 until end of data collection day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Top factors for improving weight loss outcomes	Online questionnaire - Ranking Exercise	Start of interviews day 1 until end of data collection day 90
Types of weight management goals	Online questionnaire - Multiple Item Selection	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	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	Start of interviews day 1 until end of data collection day 90
Most helpful support for weight loss	Online questionnaire - Multiple Item Selection	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)	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	Start of interviews day 1 until end of data collection day 90

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NN8022-4449; U1111-1209-6406 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No