Clinical trial NCT05428501: Awareness, Care & Treatment In Obesity Management - An Observation in Mainland China
Official title: Awareness, Care & Treatment In Obesity Management - An Observation in Mainland China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 8000
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 treatment and management

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight loss motivators
timeFrame: Day 1-day of survey
measure: PLwO / participants who made serious weight loss effort
timeFrame: Day 1-day of survey
measure: Response to/evaluation of weight loss discussion according to predefined list of values
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: Agreement with predefined Obesity and weight management measures
timeFrame: Day 1-day of survey
measure: Degree to which healthcare and society is meeting needs of PLwO
timeFrame: Day 1-day of survey
Secondary outcomes:
measure: Weight loss barriers
timeFrame: Day 1-day of survey
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 PLwO (rank of individuals/organizations in order of their responsibility)
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: Beijing
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
citation: Ji L, Mu Y, Chang C, Wang H, Zhao D, Liu D, Shen Z, Chen W. Perceptions, attitudes and barriers to effective obesity care among people living with obesity and healthcare professionals in China: The ACTION-China study. Diabetes Obes Metab. 2024 Oct;26(10):4694-4704. doi: 10.1111/dom.15837. Epub 2024 Aug 9.