Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

Obesity Clinical Trial

Official title:

Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916482
• Other study ID #: WO/BVDHYD/1/23
• Status: Recruiting
• Start date: July 14, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Chi K Hoang, MD
• Phone: (+84) 985-578-494
• Email: chi.hk[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Vietnam	My Duc General Hospital	Ho Chi Minh City
Vietnam	University Medical Center Ho Chi Minh City (Umc)	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)	M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight measurement	Using standardized weight scale (ISO 9001:2015)	At baseline
Primary	Height measurement	Using a professional medical HM200P Portable Height Stadiometer	At baseline
Primary	Body Mass Index	Weight in kilograms divided by height in meters squared	At baseline
Primary	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
Primary	Hip circumference	To be measured around the widest portion of the buttocks.	At baseline
Primary	Blood pressure	Systolic and diastolic pressure measurements will be taken using a standardized sphygmomanometer.	At baseline
Primary	Fasting plasma glucose	Fasting plasma glucose (mmol/L) concentrations in serum	At baseline
Primary	HDL cholesterol	HDL cholesterol (mmol/L) concentrations in serum	At baseline
Primary	LDL cholesterol	LDL cholesterol (mmol/L) concentrations in serum	At baseline
Primary	Triglycerides	Triglycerides (mmol/L) concentrations in serum	At baseline
Primary	Total cholesterol	Total cholesterol (mmol/L) concentrations in serum	At baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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