Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

Sponsor
University Medical Center Ho Chi Minh City (UMC) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05916482
Collaborator
Mỹ Đức Hospital (Other)
500
2
18.8
250
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characterization of Vietnamese Patients With Obesity at Outpatient Clinics
    Anticipated Study Start Date :
    Jul 10, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2025
    Anticipated Study Completion Date :
    Jan 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    OPT OBESE

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

    Outcome Measures

    Primary Outcome Measures

    1. Weight measurement [At baseline]

      Using standardized weight scale (ISO 9001:2015)

    2. Height measurement [At baseline]

      Using a professional medical HM200P Portable Height Stadiometer

    3. Body Mass Index [At baseline]

      Weight in kilograms divided by height in meters squared

    4. Waist circumference [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 [At baseline]

      To be measured around the widest portion of the buttocks.

    6. Blood pressure [At baseline]

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

    7. Fasting plasma glucose [At baseline]

      Fasting plasma glucose (mmol/L) concentrations in serum

    8. HDL cholesterol [At baseline]

      HDL cholesterol (mmol/L) concentrations in serum

    9. LDL cholesterol [At baseline]

      LDL cholesterol (mmol/L) concentrations in serum

    10. Triglycerides [At baseline]

      Triglycerides (mmol/L) concentrations in serum

    11. Total cholesterol [At baseline]

      Total cholesterol (mmol/L) concentrations in serum

    12. Body composition change [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 [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 Outcome Measures

    1. The relationship between the severity of obesity to anthropometric parameters [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 [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 [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 [At baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 My Duc General Hospital Ho Chi Minh City Vietnam 70000
    2 University Medical Center Ho Chi Minh City (Umc) Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nam Q Tran, MD, PhD, University Medical Center Ho Chi Minh City (UMC)

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Tran Quang Nam, Head of department of Endocrinology, University Medical Center Ho Chi Minh City (UMC)
    ClinicalTrials.gov Identifier:
    NCT05916482
    Other Study ID Numbers:
    • WO/BVDHYD/1/23
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tran Quang Nam, Head of department of Endocrinology, University Medical Center Ho Chi Minh City (UMC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2023