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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05690789
Other study ID # DAS-009
Secondary ID U1111-1267-0332
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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