Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584191
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Obesity Other: No treatment given

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 17287 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight loss motivators [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  2. 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

  3. Response to weight loss discussions [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Single Item Selection

  4. Effective weight loss methods [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)


Secondary Outcome Measures :
  1. Top factors for improving weight loss outcomes [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Ranking Exercise

  2. Types of weight management goals [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  3. Most helpful information for patients for weight loss [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  4. Responsibility for improving health of people with obesity [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  5. Most helpful support for weight loss [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection

  6. Effectiveness of guidelines for treating obesity [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Fully-anchored 5-point Likert scale (from "1", do not agree at all, to "5" completely agree)

  7. Ways you receive information on weight loss management [ Time Frame: Start of interviews day 1 until end of data collection day 90 ]
    Online questionnaire - Multiple Item Selection


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with obesity and health care professionals
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584191


Locations
Layout table for location information
Australia, New South Wales
Novo Nordisk Investigational Site
Baulkham Hills, New South Wales, Australia, 2153
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of
Mexico
Novo Nordisk Investigational Site
Polanco, Mexico
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland
United Arab Emirates
Novo Nordisk Investigational Site
Dubai, United Arab Emirates
United Kingdom
Novo Nordisk Investigational Site
Gatwick, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03584191    
Other Study ID Numbers: NN8022-4449
U1111-1209-6406 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight