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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)
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Secondary ID [1]
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U1111-1209-6406
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Secondary ID [2]
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NN8022-4449
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Universal Trial Number (UTN)
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Trial acronym
ACTION-IO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Weight loss motivators
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Assessment method [1]
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Online questionnaire - Multiple Item Selection
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Timepoint [1]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [2]
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Proportion of PwO / patients who made serious weight loss effort
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Assessment method [2]
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Online questionnaire - Numeric Response
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Timepoint [2]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [3]
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Response to weight loss discussions
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Assessment method [3]
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Online questionnaire - Single Item Selection
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Timepoint [3]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [4]
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Effective weight loss methods
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Assessment method [4]
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Online questionnaire - Multiple Item Selection
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Timepoint [4]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [5]
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Obesity attitudes
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Assessment method [5]
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Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree)
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Timepoint [5]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [6]
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Attitudes toward prescription weight loss medication and surgery
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Assessment method [6]
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Online questionnaire - End-anchored 5-point Likert agreement scale (from "1", do not agree at all, to "5" completely agree)
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Timepoint [6]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [7]
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Weight loss barriers
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Assessment method [7]
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Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
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Timepoint [7]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [8]
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Obesity and weight management
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Assessment method [8]
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Online questionnaire - End-anchored 5-point Likert agreement scale(from "1", do not agree at all, to "5" completely agree)
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Timepoint [8]
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Start of interviews day 1 until end of data collection day 90
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Primary outcome [9]
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Degree to which healthcare and society is meeting needs of people with obesity
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Assessment method [9]
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Online questionnaire - End-anchored 5-point Likert needs scale(from "1", do not agree at all, to "5" completely agree)
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Timepoint [9]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [1]
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Top factors for improving weight loss outcomes
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Assessment method [1]
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Online questionnaire - Ranking Exercise
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Timepoint [1]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [2]
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Types of weight management goals
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Assessment method [2]
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Online questionnaire - Multiple Item Selection
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Timepoint [2]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [3]
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Most helpful information for patients for weight loss
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Assessment method [3]
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Online questionnaire - Multiple Item Selection
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Timepoint [3]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [4]
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Responsibility for improving health of people with obesity
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Assessment method [4]
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Online questionnaire - Multiple Item Selection
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Timepoint [4]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [5]
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Most helpful support for weight loss
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Assessment method [5]
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Online questionnaire - Multiple Item Selection
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Timepoint [5]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [6]
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Effectiveness of guidelines for treating obesity
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Assessment method [6]
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Online questionnaire - Fully-anchored 5-point Likert scale (from "1", do not agree at all, to "5" completely agree)
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Timepoint [6]
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Start of interviews day 1 until end of data collection day 90
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Secondary outcome [7]
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Ways you receive information on weight loss management
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Assessment method [7]
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Online questionnaire - Multiple Item Selection
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Timepoint [7]
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Start of interviews day 1 until end of data collection day 90
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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)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/10/2018
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Sample size
Target
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Accrual to date
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Final
17287
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Baulkham Hills
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Recruitment postcode(s) [1]
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2153 - Baulkham Hills
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
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Kfar Saba
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Country [2]
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Korea, Republic of
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State/province [2]
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Seoul
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Country [3]
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Mexico
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State/province [3]
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Polanco
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Country [4]
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Saudi Arabia
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State/province [4]
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Riyadh
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Country [5]
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Spain
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State/province [5]
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Madrid
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Country [6]
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Switzerland
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State/province [6]
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Zürich
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Country [7]
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United Arab Emirates
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State/province [7]
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Dubai
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Country [8]
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United Kingdom
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State/province [8]
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Gatwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03584191
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Reporting Anchor and Disclosure (1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03584191
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