Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OPT OBESE<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Vietnamese patients with obesity, Outpatient clinic