Clinical trial NCT05916482: Characterization of Vietnamese Patients With Obesity at Outpatient Clinics
Official title: Characterization of Vietnamese Patients With Obesity at Outpatient Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Vietnamese patients with obesity
Outpatient clinic
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
Collaborators: name: Mỹ Đức Hospital
First posted: 2023-06-23
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight measurement
timeFrame: At baseline
measure: Height measurement
timeFrame: At baseline
measure: Body Mass Index
timeFrame: At baseline
measure: Waist circumference
timeFrame: At baseline
measure: Hip circumference
timeFrame: At baseline
measure: Blood pressure
timeFrame: At baseline
measure: Fasting plasma glucose
timeFrame: At baseline
measure: HDL cholesterol
timeFrame: At baseline
measure: LDL cholesterol
timeFrame: At baseline
measure: Triglycerides
timeFrame: At baseline
measure: Total cholesterol
timeFrame: At baseline
measure: Body composition change
timeFrame: At baseline
measure: Risk of depression score
timeFrame: At baseline
Secondary outcomes:
measure: The relationship between the severity of obesity to anthropometric parameters
timeFrame: At baseline
measure: The relationship between the severity of obesity to biochemical parameters
timeFrame: At baseline
measure: The relationship between the severity of obesity to body composition
timeFrame: At baseline
measure: The relationship between the severity of obesity to risk of depression
timeFrame: At baseline
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc General Hospital
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City (Umc)
Study officials:
affiliation: University Medical Center Ho Chi Minh City (UMC)
name: Nam Q Tran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: