Awareness, Care & Treatment In Obesity Management (ACTION-France)

June 13, 2023 updated by: Novo Nordisk A/S

Awareness, Care & Treatment In Obesity Management - An Observation in France

ACTION France is a cross-sectional, observational, descriptive, and exploratory survey-based study without collection of laboratory data. The study is not related to any specific treatment options or pharmaceutical product. Collection of data will be performed via quantitative online survey by a third-party vendor.

The goal of this study is to provide insights to drive awareness around the needs of People Living with Obesity (PLwO) and Health Care Professionals (HCPs) involved in obesity treatment and management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1688

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Puteaux, France, 92800
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The respondent population will include people living with obesity (PLwO) and health care professionals (HCPs) involved in obesity treatmen, management and employers

Description

Inclusion Criteria:

People Living with Obesity

  1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  2. Male or female, aged above or equal to 18 years at the time of signing informed consent Lives in France
  3. Current BMI based on self-reported height and weight of at least 30 kg/m^2

Health Care Professionals

  1. Informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol)
  2. Male or female, aged greater than or equal to 18 years at the time of signing informed consent.
  3. Physician with a license to practice
  4. Specialty is not surgeon (including bariatric or plastic surgeon)
  5. Practices in France
  6. In clinical practice greater than or equal to 2 years
  7. Spends at least 70 percent time in direct patient care
  8. Has seen at least 100 patients in past month
  9. 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/m^2 with or without comorbidities.

Employers

  1. Informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol)
  2. Age 18 years old or older
  3. works in France
  4. Company offers health insurance benefits
  5. Responsible for making or influencing decisions about employee benefits plan or health and wellness programs
  6. works in a company that has at least 20 employees
  7. not affiliated with pharma, MR or advertising firms

Exclusion Criteria:

People Living with obesity

  1. Previous participation in this study. Participation is defined as having given online consent in this study
  2. Currently pregnant
  3. Participates in intense fitness or body building programs
  4. Has had significant, unintentional weight loss (due to major injury, illness, etc) in the past 6 months
  5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Health Care Providers

  1. Previous participation in this study. Participation is defined as having given informed consent in this study.
  2. Unwillingness, inability, or language barriers precluding adequate understanding or cooperation.

Employers

  1. Previous participation in this study. Participation is defined as having given informed consent in this study.
  2. Unwillingness, inability, or language barriers precluding adequate understanding or cooperation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
People / Person Living with Obesity (PLwO)
From online, general population consumer panels
Other: No treatment given
No treatment given
Health Care Professionals (HCPs)
HCPs treating people who have obesity
Other: No treatment given
No treatment given
Employers
Single-selection response from defined list
Other: No treatment given
No treatment given

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight loss motivators
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Proportion of PLwO / participants who made serious weight loss effort
Time Frame: Day 1-day of survey
Percentage of participants
Day 1-day of survey
Response to weight loss discussions
Time Frame: Day 1-day of survey
Single select from defined list
Day 1-day of survey
Effective weight loss methods
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Weight loss barriers
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Obesity attitudes
Time Frame: Day 1-day of survey

5-point Likert scale

1=strongly disagree to 5=strongly agree
Day 1-day of survey
Attitudes toward prescription weight loss medication and surgery
Time Frame: Day 1-day of survey

5-point Likert scale

1=strongly disagree to 5=strongly agree
Day 1-day of survey
Obesity and weight management
Time Frame: Day 1-day of survey

5-point Likert scale

1=strongly disagree to 5=strongly agree
Day 1-day of survey
Degree to which healthcare and society is meeting needs of people living with obesity
Time Frame: Day 1-day of survey

5-point Likert scale

1=strongly disagree to 5=strongly agree
Day 1-day of survey

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Top factors for improving weight loss outcomes
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Types of weight management goals
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Most helpful information for participants for weight loss
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Responsibility for improving health of people living with obesity
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Most helpful support for weight loss
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Ways participants receive information on weight loss management
Time Frame: Day 1-day of survey
Multi-select from defined list
Day 1-day of survey
Effectiveness of guidelines for treating obesity
Time Frame: Day 1-day of survey

5-point Likert scale

1=strongly disagree to 5=strongly agree
Day 1-day of survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAS-009
  • U1111-1267-0332 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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