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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: no treatment given

• Study Type: Observational
• Enrollment (Actual): 8000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health Care Professionals (HCPs); HCPs treating people who have obesity	Other: no treatment given; People / Person Living with Obesity (PLwO) Health Care Professionals (HCPs)
Person Living with Obesity (PLwO); PLwO recruited via online platforms or face-to-face channels	Other: no treatment given; People / Person Living with Obesity (PLwO) Health Care Professionals (HCPs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss motivators	Multi-selection from defined list	Day 1-day of survey
PLwO / participants who made serious weight loss effort	Percentage of participants	Day 1-day of survey
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
Effective weight loss methods	Multi-selection from defined list	Day 1-day of survey
Obesity attitudes	5-point Likert scales: 1: Do not agree at all 5: Completely agree	Day 1-day of survey
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss barriers	Multi-selection from defined list	Day 1-day of survey
Top factors for improving weight loss outcomes	Multi-selection from defined list	Day 1-day of survey
Types of weight management goals	Multi-selection from defined list	Day 1-day of survey
Most helpful information for participants for weight loss	Multi-selection from defined list	Day 1-day of survey
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
Most helpful support for weight loss	Multi-selection from defined list	Day 1-day of survey
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
Ways participants receive information on weight loss management	Multi-selection from defined list	Day 1-day of survey

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 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-004; U1111-1266-4279 (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