NCT03584191

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
9 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

June 29, 2018

Last Update Submit

May 22, 2019

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (7)

  • Top factors for improving weight loss outcomes

    Start of interviews day 1 until end of data collection day 90

  • Types of weight management goals

    Start of interviews day 1 until end of data collection day 90

  • Most helpful information for patients for weight loss

    Start of interviews day 1 until end of data collection day 90

  • Responsibility for improving health of people with obesity

    Start of interviews day 1 until end of data collection day 90

  • Most helpful support for weight loss

    Start of interviews day 1 until end of data collection day 90

  • +2 more secondary outcomes

Study Arms (2)

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

Health Care Professionals

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

Other: No treatment given

Interventions

Completion of a survey

Health Care ProfessionalsPeople with Obesity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with obesity and health care professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novo Nordisk Investigational Site

Baulkham Hills, New South Wales, 2153, Australia

Location

Novo Nordisk Investigational Site

Kfar Saba, 44425, Israel

Location

Novo Nordisk Investigational Site

Polanco, Mexico

Location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Location

Novo Nordisk Investigational Site

Seoul, South Korea

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Zurich, Switzerland

Location

Novo Nordisk Investigational Site

Dubai, United Arab Emirates

Location

Novo Nordisk Investigational Site

Gatwick, United Kingdom

Location

Related Publications (7)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Reporting Anchor and Disclosure (1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

June 4, 2018

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations