ObesityACTION-FranceNCT05690789
Awareness, Care & Treatment In Obesity Management
An observational study of Obesity, run by Novo Nordisk A/S at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- No treatment given
- How many people
- 1,688 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The respondent population will include people living with obesity (PLwO) and health care professionals (HCPs) involved in obesity treatmen, management and employers
Who may be able to join
- People Living with Obesity
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, aged above or equal to 18 years at the time of signing informed consent Lives in France
- Current BMI based on self-reported height and weight of at least 30 kg/m^2
- Health Care Professionals
- Informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol)
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- Male or female, aged greater than or equal to 18 years at the time of signing informed consent.
- Physician with a license to practice
- Specialty is not surgeon (including bariatric or plastic surgeon)
- Practices in France
- In clinical practice greater than or equal to 2 years
- Spends at least 70 percent 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/m^2 with or without comorbidities.
- Employers
- Informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol)
- Age 18 years old or older
- works in France
- Company offers health insurance benefits
- Responsible for making or influencing decisions about employee benefits plan or health and wellness programs
- works in a company that has at least 20 employees
- not affiliated with pharma, MR or advertising firms
Who cannot join
- People Living with obesity
- Previous participation in this study. Participation is defined as having given online consent in this study
- 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
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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- Health Care Providers
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
- Employers
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- No treatment given
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| People / Person Living with Obesity (PLwO) | From online, general population consumer panels Receives: Other: No treatment given | |
| Health Care Professionals (HCPs) | HCPs treating people who have obesity Receives: Other: No treatment given | |
| Employers | Single-selection response from defined list Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss motivators
Multi-select from defined list
Measured: Day 1-day of survey
Proportion of PLwO / participants who made serious weight loss effort
Percentage of participants
Measured: Day 1-day of survey
Response to weight loss discussions
Single select from defined list
Measured: Day 1-day of survey
Effective weight loss methods
Multi-select from defined list
Measured: Day 1-day of survey
Obesity attitudes
5-point Likert scale
1=strongly disagree to 5=strongly agree
Measured: Day 1-day of survey
Attitudes toward prescription weight loss medication and surgery
5-point Likert scale
1=strongly disagree to 5=strongly agree
Measured: Day 1-day of survey
Weight loss barriers
Multi-select from defined list
Measured: Day 1-day of survey
Obesity and weight management
5-point Likert scale
1=strongly disagree to 5=strongly agree
Measured: Day 1-day of survey
Degree to which healthcare and society is meeting needs of people living with obesity
5-point Likert scale
1=strongly disagree to 5=strongly agree
Measured: Day 1-day of survey
Secondary outcomes (7)
Top factors for improving weight loss outcomes
Multi-select from defined list
Measured: Day 1-day of survey
Types of weight management goals
Multi-select from defined list
Measured: Day 1-day of survey
Most helpful information for participants for weight loss
Multi-select from defined list
Measured: Day 1-day of survey
Responsibility for improving health of people living with obesity
Multi-select from defined list
Measured: Day 1-day of survey
Most helpful support for weight loss
Multi-select from defined list
Measured: Day 1-day of survey
Effectiveness of guidelines for treating obesity
5-point Likert scale
1=strongly disagree to 5=strongly agree
Measured: Day 1-day of survey
Ways participants receive information on weight loss management
Multi-select from defined list
Measured: Day 1-day of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start27 Sep 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690789
- Sponsor's protocol ID
- DAS-009
- Other IDs
- U1111-1267-0332
- Acronym
- ACTION-France
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness, Care & Treatment In Obesity Management - An Observation in France
- ClinicalTrials.gov ID
- NCT05690789
- Acronym / sponsor ID
- ACTION-France / DAS-009
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,688 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People / Person Living with Obesity (PLwO) | – | Other: No treatment givenFrom online, general population consumer panels |
| Health Care Professionals (HCPs) | – | Other: No treatment givenHCPs treating people who have obesity |
| Employers | – | Other: No treatment givenSingle-selection response from defined list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The respondent population will include people living with obesity (PLwO) and health care professionals (HCPs) involved in obesity treatmen, management and employers
Key inclusion criteria (22 listed)
- People Living with Obesity
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, aged above or equal to 18 years at the time of signing informed consent Lives in France
- Current BMI based on self-reported height and weight of at least 30 kg/m^2
- Health Care Professionals
Key exclusion criteria (12 listed)
- People Living with obesity
- Previous participation in this study. Participation is defined as having given online consent in this study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | Employers, Health Care Professionals (HCPs), People / Person Living with Obesity (PLwO) |
Primary outcome
Weight loss motivators
Time frame: Day 1-day of survey
Multi-select from defined list
Proportion of PLwO / participants who made serious weight loss effort
Time frame: Day 1-day of survey
Percentage of participants
Response to weight loss discussions
Time frame: Day 1-day of survey
Single select from defined list
Effective weight loss methods
Time frame: Day 1-day of survey
Multi-select from defined list
Obesity attitudes
Time frame: Day 1-day of survey
5-point Likert scale 1=strongly disagree to 5=strongly agree
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
Weight loss barriers
Time frame: Day 1-day of survey
Multi-select from defined list
Obesity and weight management
Time frame: Day 1-day of survey
5-point Likert scale 1=strongly disagree to 5=strongly agree
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
7 secondary outcomes
Top factors for improving weight loss outcomes
Time frame: Day 1-day of survey
Types of weight management goals
Time frame: Day 1-day of survey
Most helpful information for participants for weight loss
Time frame: Day 1-day of survey
Responsibility for improving health of people living with obesity
Time frame: Day 1-day of survey
Most helpful support for weight loss
Time frame: Day 1-day of survey
Effectiveness of guidelines for treating obesity
Time frame: Day 1-day of survey
Ways participants receive information on weight loss management
Time frame: Day 1-day of survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss motivators (time frame: Day 1-day of survey). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.