Awareness, Care & Treatment In Obesity Management

Obesity Clinical Trial

— ACTION-France  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690789
• Other study ID #: DAS-009
• Secondary ID: U1111-1267-0332
• Status: Completed
• Start date: September 27, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1688
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Puteaux

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss motivators	Multi-select from defined list	Day 1-day of survey
Primary	Proportion of PLwO / participants who made serious weight loss effort	Percentage of participants	Day 1-day of survey
Primary	Response to weight loss discussions	Single select from defined list	Day 1-day of survey
Primary	Effective weight loss methods	Multi-select from defined list	Day 1-day of survey
Primary	Obesity attitudes	5-point Likert scale; 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Primary	Attitudes toward prescription weight loss medication and surgery	5-point Likert scale; 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Primary	Weight loss barriers	Multi-select from defined list	Day 1-day of survey
Primary	Obesity and weight management	5-point Likert scale; 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Primary	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	Day 1-day of survey
Secondary	Top factors for improving weight loss outcomes	Multi-select from defined list	Day 1-day of survey
Secondary	Types of weight management goals	Multi-select from defined list	Day 1-day of survey
Secondary	Most helpful information for participants for weight loss	Multi-select from defined list	Day 1-day of survey
Secondary	Responsibility for improving health of people living with obesity	Multi-select from defined list	Day 1-day of survey
Secondary	Most helpful support for weight loss	Multi-select from defined list	Day 1-day of survey
Secondary	Effectiveness of guidelines for treating obesity	5-point Likert scale; 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Secondary	Ways participants receive information on weight loss management	Multi-select from defined list	Day 1-day of survey