Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

In the past three decades, obesity has emerged insurmountably, not only in affluent nations but also in many low- and middle-income countries worldwide. It has been linked to various non-communicable diseases, including hypertension, coronary heart disease, diabetes mellitus, dyslipidemia, stroke, colorectal cancer, and many other chronic conditions, such as musculoskeletal disorders, putting tremendous pressure on healthcare systems and the socio-economy. The Asia and Pacific region harbors the highest absolute number of people with overweight and obese, amounting to approximately 1 billion. In Southeast Asia, the prevalence of overweight and obesity increased by almost 40% between 1990 and 2013. Although Vietnam has the lowest percentage of obese adults in the region (about 3.6%), we experienced a 38% increase in the number of obese people between 2010-2014, much higher than that in the University Kingdom and the United States (10% and 8% correspondingly). However, the problem is underestimated by not only healthcare professionals but also patients with obesity. These alarms underscore the necessity of implementing a comprehensive assessment and more focused and practical strategies for addressing obesity in Vietnam, where data has been limited. Therefore, our research has two arms: (1) characterization of patients with obesity to identify those at the highest risks for obesity complications, and (2) understating the attitudes and perceptions of people living with obesity to gain insights into the psychological factors associated with obesity. This research will be a foundation for further research on obesity in Vietnam and Southeast Asia.

Study Overview

• Status: Completed
• Conditions: Obesity

Detailed Description

All Vietnamese, aged 18-65, diagnosed with obesity defined by BMI ≥ 25 kg/m2 as per Asia-Pacific Guidelines for Obesity, present at University Medical Center Ho Chi Minh City and My Duc General Hospital outpatient clinics, will be enrolled to the study. The patients will have:

• Standard anthropometric data will be done, using a professional medical HM200P Portable Height Stadiometer and a standardised ISO (International Organization for Standardization) 9001:2015 weight scale, by professional and experienced physicians according to standard study protocol: Weight, height, waist and hip circumference, waist to hip ratio, BMI calculated, followed by World Health Organization guidelines for Asian people.
• Blood pressure measure.
• Fat mass measured by the Tanita MC-780 MA (Serial: 17050004).
• Blood tests: fasting plasma glucose, cholesterol, HDL-C, LDL-C, and triglyceride.
• Mood disorder screening by answering a Patient Health Questionnaire-9.

• Study Type: Observational
• Enrollment (Actual): 502

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • My Duc General Hospital
  • Ho Chi Minh City, Vietnam, 70000
    • University Medical Center Ho Chi Minh City (UMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All Vietnamese, aged 18-65, diagnosed with obesity defined by BMI ≥ 25 kg/m2 as per Asia-Pacific Guidelines for Obesity, present at University Medical Center Ho Chi Minh City and My Duc General Hospital outpatient clinics will be enrolled to the study.

Description

Inclusion Criteria:

• Subject is diagnosed with obesity defined by BMI ≥ 25 kg/m2

Exclusion Criteria:

• Inability to cooperate with height measurement.
• Inability to answer questionnaire.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OPT OBESE; Vietnamese patients with obesity present at outpatient clinics of University Medical Center Ho Chi Minh City and My Duc General Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight measurement	Using standardized weight scale (ISO 9001:2015)	At baseline
Height measurement	Using a professional medical HM200P Portable Height Stadiometer	At baseline
Body Mass Index	Weight in kilograms divided by height in meters squared	At baseline
Waist circumference	To be measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest	At baseline
Hip circumference	To be measured around the widest portion of the buttocks.	At baseline
Blood pressure	Systolic and diastolic pressure measurements will be taken using a standardized sphygmomanometer.	At baseline
Fasting plasma glucose	Fasting plasma glucose (mmol/L) concentrations in serum	At baseline
HDL cholesterol	HDL cholesterol (mmol/L) concentrations in serum	At baseline
LDL cholesterol	LDL cholesterol (mmol/L) concentrations in serum	At baseline
Triglycerides	Triglycerides (mmol/L) concentrations in serum	At baseline
Total cholesterol	Total cholesterol (mmol/L) concentrations in serum	At baseline
Body composition change	Body fat mass (% BFM), body fat percentage (%BF), muscle mass, skeletal muscle mass (% SMM) and visceral fat rating will be evaluated to assess body composition change. Measurements will be assessed using a Electrical bioimpedance (BIA)	At baseline
Risk of depression score	Risk of depression will be assessed using PHQ-9 (Patient Health Questionnaire-9). It is scored on a 27-point scale. Those with a PHQ-9 score less than five is considered at no risk of depression, and those with a PHQ-9 score equal to or more than 5 are at risk of depression.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between the severity of obesity to anthropometric parameters	The correlation between the severity of obesity to anthropometric parameters (waist circumference, hip circumference, weight, height, and BMI) will be evaluated.	At baseline
The relationship between the severity of obesity to biochemical parameters	The correlation between the severity of obesity to biochemical parameters (fasting plasma glucose, LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol) will be evaluated.	At baseline
The relationship between the severity of obesity to body composition	The correlation between the severity of obesity to body composition (body fat mass (% BFM), body fat percentage (%BF), muscle mass, skeletal muscle mass (% SMM) and visceral fat rating) will be evaluated.	At baseline
The relationship between the severity of obesity to risk of depression	The correlation between the severity of obesity to risk of depression (PHQ-9 score) will be evaluated.	At baseline

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)
• Collaborators: Mỹ Đức Hospital
• Investigators: Principal Investigator: Nam Q Tran, MD, PhD, University Medical Center Ho Chi Minh City (UMC)

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Outpatient clinic; Vietnamese patients with obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: WO/BVDHYD/1/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No