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

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: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 1688

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Weight loss motivators	Multi-select from defined list	Day 1-day of survey
Proportion of PLwO / participants who made serious weight loss effort	Percentage of participants	Day 1-day of survey
Response to weight loss discussions	Single select from defined list	Day 1-day of survey
Effective weight loss methods	Multi-select from defined list	Day 1-day of survey
Weight loss barriers	Multi-select from defined list	Day 1-day of survey
Obesity attitudes	5-point Likert scale 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Attitudes toward prescription weight loss medication and surgery	5-point Likert scale 1=strongly disagree to 5=strongly agree	Day 1-day of survey
Obesity and weight management	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	5-point Likert scale 1=strongly disagree to 5=strongly agree	Day 1-day of survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Top factors for improving weight loss outcomes	Multi-select from defined list	Day 1-day of survey
Types of weight management goals	Multi-select from defined list	Day 1-day of survey
Most helpful information for participants for weight loss	Multi-select from defined list	Day 1-day of survey
Responsibility for improving health of people living with obesity	Multi-select from defined list	Day 1-day of survey
Most helpful support for weight loss	Multi-select from defined list	Day 1-day of survey
Ways participants receive information on weight loss management	Multi-select from defined list	Day 1-day of survey
Effectiveness of guidelines for treating obesity	5-point Likert scale 1=strongly disagree to 5=strongly agree	Day 1-day of survey

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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