Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

NCT05916482 | Completed

• 1 other identifier: WO/BVDHYD/1/23
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity

Keywords

Obesity; Vietnamese patients with obesity; Outpatient clinic

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (4)

• The relationship between the severity of obesity to anthropometric parameters

  At baseline

• The relationship between the severity of obesity to biochemical parameters

  At baseline

• The relationship between the severity of obesity to body composition

  At baseline

• The relationship between the severity of obesity to risk of depression

  At baseline

Study Arms (1)

OPT OBESE

Vietnamese patients with obesity present at outpatient clinics of University Medical Center Ho Chi Minh City and My Duc General Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead
• Mỹ Đức Hospital: collaborator

Study Sites (2)

My Duc General Hospital

Ho Chi Minh City, 70000, Vietnam

Location

University Medical Center Ho Chi Minh City (Umc)

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nam Q Tran, MD, PhD

  University Medical Center Ho Chi Minh City (UMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Endocrinology

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 23, 2023
• Study Start: July 14, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)