Clinical trial NCT05690789: Awareness, Care & Treatment In Obesity Management
Official title: Awareness, Care & Treatment In Obesity Management - An Observation in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 1688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss motivators
timeFrame: Day 1-day of survey
measure: Proportion of PLwO / participants who made serious weight loss effort
timeFrame: Day 1-day of survey
measure: Response to weight loss discussions
timeFrame: Day 1-day of survey
measure: Effective weight loss methods
timeFrame: Day 1-day of survey
measure: Obesity attitudes
timeFrame: Day 1-day of survey
measure: Attitudes toward prescription weight loss medication and surgery
timeFrame: Day 1-day of survey
measure: Weight loss barriers
timeFrame: Day 1-day of survey
measure: Obesity and weight management
timeFrame: Day 1-day of survey
measure: Degree to which healthcare and society is meeting needs of people living with obesity
timeFrame: Day 1-day of survey
Secondary outcomes:
measure: Top factors for improving weight loss outcomes
timeFrame: Day 1-day of survey
measure: Types of weight management goals
timeFrame: Day 1-day of survey
measure: Most helpful information for participants for weight loss
timeFrame: Day 1-day of survey
measure: Responsibility for improving health of people living with obesity
timeFrame: Day 1-day of survey
measure: Most helpful support for weight loss
timeFrame: Day 1-day of survey
measure: Effectiveness of guidelines for treating obesity
timeFrame: Day 1-day of survey
measure: Ways participants receive information on weight loss management
timeFrame: Day 1-day of survey
Other outcomes:
Locations:
city: Puteaux
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: