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

Obesity Clinical Trial

— ACTION China  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428501
• Other study ID #: DAS-004
• Secondary ID: U1111-1266-4279
• Status: Completed
• Start date: August 18, 2022
• Est. completion date: November 30, 2022

Study information

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

Clinical Trial Summary

ACTION China 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: 8000
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

PLwO:

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

3. Lives in mainland China and is native Chinese

4. Current BMI based on self-reported height and weight of at least 28 kg/m^2 as per mainland China definition of obesity(16) (calculated using an algorithm within the survey instrument)

HCPs:

1. Informed consent obtained before any study related activities (study-related activities are any procedure related to recording/collection of data according to the protocol)

2. Male or female, aged greather than or equal to18 years at the time of signing informed consent.

3. Physician with a license to practice

4. Specialty is not surgeon (including general, bariatric or plastic surgeon)

5. Practices in mainland China with at least 5 years in clinical practice

6. Spends at least 50% of time in direct patient care (as opposed to surgical procedures, office procedures or research/administrative tasks)

7. Has seen at least 100 patients in the past month

8. Has seen at least 10 patients needing weight management (defined as a patient with a BMI greather than or equal to28 kg/m^2 with or without comorbidities) in the past month

Exclusion criteria:

PLwO

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 HCPs

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
People / Person Living with Obesity (PLwO) Health Care Professionals (HCPs)

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss motivators	Multi-selection from defined list	Day 1-day of survey
Primary	PLwO / participants who made serious weight loss effort	Percentage of participants	Day 1-day of survey
Primary	Response to/evaluation of weight loss discussion according to predefined list of values	Single selection from defined list; Not at all helpful; A little helpful; Somewhat helpful; Very helpful; Extremely helpful	Day 1-day of survey
Primary	Effective weight loss methods	Multi-selection from defined list	Day 1-day of survey
Primary	Obesity attitudes	5-point Likert scales: 1: Do not agree at all 5: Completely agree	Day 1-day of survey
Primary	Attitudes toward prescription weight loss medication and surgery	5-point Likert scales: 1: Do not agree at all 5: Completely agree	Day 1-day of survey
Primary	Agreement with predefined Obesity and weight management measures	5-point Likert scales: 1: Do not agree at all 5: Completely agree	Day 1-day of survey
Primary	Degree to which healthcare and society is meeting needs of PLwO	5-point Likert scales: 1: Not at all meeting the needs 5: Completely meeting the needs	Day 1-day of survey
Secondary	Weight loss barriers	Multi-selection from defined list	Day 1-day of survey
Secondary	Top factors for improving weight loss outcomes	Multi-selection from defined list	Day 1-day of survey
Secondary	Types of weight management goals	Multi-selection from defined list	Day 1-day of survey
Secondary	Most helpful information for participants for weight loss	Multi-selection from defined list	Day 1-day of survey
Secondary	Responsibility for improving health of PLwO (rank of individuals/organizations in order of their responsibility)	Rank of multi-selection from defined list of individuals/organizations in order of their responsibility.; Ranks 1 - 3 where "1" means most responsible and "3" means least responsible	Day 1-day of survey
Secondary	Most helpful support for weight loss	Multi-selection from defined list	Day 1-day of survey
Secondary	Effectiveness of guidelines for treating obesity	5-point Likert scales: Not at all effective; A little effective; Somewhat effective; Very effective; Extremely effective	Day 1-day of survey
Secondary	Ways participants receive information on weight loss management	Multi-selection from defined list	Day 1-day of survey