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NCT Number: NCT05916482

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

My Duc General Hospital, Ho Chi Minh City, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Weight measurement

    Time frame: At baseline

    Using standardized weight scale (ISO 9001:2015)

  2. Height measurement

    Time frame: At baseline

    Using a professional medical HM200P Portable Height Stadiometer

  3. Body Mass Index

    Time frame: At baseline

    Weight in kilograms divided by height in meters squared

  4. Waist circumference

    Time frame: At baseline

    To be measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest

  5. Hip circumference

    Time frame: At baseline

    To be measured around the widest portion of the buttocks.

  6. Blood pressure

    Time frame: At baseline

    Systolic and diastolic pressure measurements will be taken using a standardized sphygmomanometer.

  7. Fasting plasma glucose

    Time frame: At baseline

    Fasting plasma glucose (mmol/L) concentrations in serum

  8. HDL cholesterol

    Time frame: At baseline

    HDL cholesterol (mmol/L) concentrations in serum

  9. LDL cholesterol

    Time frame: At baseline

    LDL cholesterol (mmol/L) concentrations in serum

  10. Triglycerides

    Time frame: At baseline

    Triglycerides (mmol/L) concentrations in serum

  11. Total cholesterol

    Time frame: At baseline

    Total cholesterol (mmol/L) concentrations in serum

  12. Body composition change

    Time frame: At baseline

    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)

  13. Risk of depression score

    Time frame: At baseline

    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.

Secondary outcomes

  1. The relationship between the severity of obesity to anthropometric parameters

    Time frame: At baseline

    The correlation between the severity of obesity to anthropometric parameters (waist circumference, hip circumference, weight, height, and BMI) will be evaluated.

  2. The relationship between the severity of obesity to biochemical parameters

    Time frame: At baseline

    The correlation between the severity of obesity to biochemical parameters (fasting plasma glucose, LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol) will be evaluated.

  3. The relationship between the severity of obesity to body composition

    Time frame: At baseline

    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.

  4. The relationship between the severity of obesity to risk of depression

    Time frame: At baseline

    The correlation between the severity of obesity to risk of depression (PHQ-9 score) will be evaluated.

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Collaborators

  • Mỹ Đức Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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