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CTRI Number  CTRI/2025/01/079165 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Weight-Related Health Problems in Different Weight Groups Across India, Pakistan, Philippines, and Vietnam 
Scientific Title of Study   Prevalence of weight related complications across Diverse Weight Classifications – A large cross-sectional study in India, Pakistan, Philippines and Vietnam 
Trial Acronym  WEIGHT DIVERSE Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Manjunath 
Designation  Senior Medical Manager Obesity 
Affiliation  Novo Nordisk India Private Limited 
Address  NXT 2, 1 and 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Venkateshapura, Bangalore North

Bangalore
KARNATAKA
560045
India 
Phone  9148263232  
Fax  0  
Email  apmh@novonordisk.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aparna Manjunath 
Designation  Senior Medical Manager Obesity 
Affiliation  Novo Nordisk India Private Limited 
Address  NXT 2, 1 and 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Venkateshapura, Bangalore North

Bangalore
KARNATAKA
560045
India 
Phone  9148263232  
Fax  0  
Email  apmh@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Aparna Manjunath 
Designation  Senior Medical Manager Obesity 
Affiliation  Novo Nordisk India Private Limited 
Address  NXT 2, 1 and 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Venkateshapura, Bangalore North

Bangalore
KARNATAKA
560045
India 
Phone  9148263232  
Fax  0  
Email  apmh@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Limited 
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  NXT 2, 1 & 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Venkateshapura, Bangalore North, 560045, Karnataka, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Pakistan
Philippines
Viet Nam  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naval K Vikram  All India Institute Of Medical Sciences  Room No.17,SRB Lab, 3rd floor, Department of Medicine, Teaching Block, Emergency building, AIIMS New Delhi-110029
New Delhi
DELHI 		 9810007331

navalvikram@gmail.com 
Dr Paramesh Shamanna  Bangalore Diabetes Centre and Diagnostic Lab  Room No.1, Ground Floor, Department of Diabetology, No.426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore-560043
Bangalore
KARNATAKA 		 9845010610

drparamesh2@gmail.com 
Dr Neeta Deshpande  Belgaum Diabetes Centre  Ground and Second Floor, CTS 1574/1575, Maruti Galli, Belagavi, Karnataka-590001
Belgaum
KARNATAKA 		 9880271313

neetarohit@gmail.com 
Dr Sambit Das  Endeavour Clinic - Centre of Diabetes and Endocrinology  Plot No. N2/192, Post office Lane, Block N2, IRC Village, Nayapalli, Bhubaneswar, Odisha-751015
Khordha
ORISSA 		 8093060177

drsambitendocrine@gmail.com 
Dr Sujoy Ghosh  Institute of Post Graduate Medical Education and Research and SSKM Hospital  4th Floor, Department of Endocrinology, Ronald Ross Building, 244, AJC Bose Road, Kolkata -700020
Kolkata
WEST BENGAL 		 9674625823

drsujoyghosh2000@gmail.com 
Dr Shehla Shaikh  K.G.N Diabetes and Endocrinology Centre  Room No.10, 1st Floor, Patel Arcade, Kedy Shopping Centre, Nagpada Junction, Mumbai-400008
Mumbai
MAHARASHTRA 		 9820984842

drshehla@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
Institute Ethics Committee-All India Institute of Medical Sciences   Approved 
Institutional Ethics Committee - Sparsh Hospitals and Critical Care Private Limited  Approved 
Lakeview Ethics Committee  Approved 
Medisys Clinisearch Ethical Review Board  Approved 
Vision Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E668||Other obesity, (3) ICD-10 Condition: E663||Overweight,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. Male or female aged 18 years or older at the time of signing informed consent.

3. Presence of atleast one Weight-related complication. complications. 
 
ExclusionCriteria 
Details  1. Participants aged less than 18 years at the time of signing informed consent.

2. Pregnant women and individuals with recent weight loss due to illness, defined as more than 5%
weight loss in the past 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of weight-related complications across
different BMI classes 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of weight-related complications across different anthropometric measurements and body indices, such as waist circumference, waist-height ratio, waist-hip ratio, and parameters of body composition analysis (Bioimpedance analysis [Optional])  Baseline 
 
Target Sample Size   Total Sample Size="1165"
Sample Size from India="432" 
Final Enrollment numbers achieved (Total)= "1170"
Final Enrollment numbers achieved (India)="432" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) 31/03/2026 
Date of First Enrollment (Global)  15/04/2025 
Date of Study Completion (Global) 31/03/2026 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The prevalence of obesity and obesity-related complications in India, Pakistan, Philippines and Vietnam is a poses a significant healthcare problem. But there is a concern that using the existing BMI cut-offs, which are applicable to Caucasians may not accurately reflect the extent of the problem., which may not accurately reflect the prevalence of obesity-related complications in the South Asian population. Reports from the World Health Organization (WHO) as early as 2000 and
the Southeast Asian Consensus report in 2022 underscore this discrepancy. Moreover, the current Asian South Asian/Southeast Asian BMI classification for obesity requires further validation through larger evidence-based studies, particularly in correlation with weight-related complications, with limited evidence available from studies such as Kapoor Kerala study. In Pakistan, studies such as Ali et al. (2018) highlight that the conventional BMI thresholds may underestimate the prevalence of obesity-related health risks among the Pakistani population. Similar concerns are echoed in the Philippines, where research by Santos et al. (2020) suggests that lower BMI cut-offs might be more predictive of metabolic syndromes and cardiovascular diseases in the Filipino population. In Vietnam, Nguyen et al. (2019) provide evidence that the general BMI guidelines do not align well with the health outcomes related to obesity in Vietnamese adults, suggesting a need for region-specific adjustments.
These studies collectively indicate a critical need for revisiting and possibly revising the BMI classifications used for these populations to better predict and manage the health risks associated with obesity.

In the broader Asia-Pacific region, including the Philippines and Vietnam, challenges related to obesity care are also prominent. The "ACTION APAC: Understanding perceptions, attitudes and behaviours in obesity and its management across South and Southeast Asia" study provides valuable insights into the perceptions, attitudes, and behaviours related to obesity management in these countries. Significantly, the study reveals that a notable proportion of individuals with obesity perceive themselves to be of normal weight or overweight, potentially denying their obesity status. This observation emphasizes the need for a deeper understanding of the perceptions, attitudes, and behaviours related to obesity in the region.

Additionally, while a survey from 6 European countries has demonstrated a link between obesity related complications and increased Healthcare Resource Utilization (HCRU), there is a lack of data pertaining to South-East Asia in this regard. This highlights the need for comprehensive data from the Asia-Pacific region to inform effective obesity management strategies. 

The proposed large cross-sectional study aims to Complement the findings of the ACTION APAC study and provide a comprehensive understanding of the prevalence of weight-related complications across diverse weight classifications in India, Pakistan, Philippines, and Vietnam. The study seeks to validate the existing BMI classification for obesity in the region and establish correlations with weight-related complications. Furthermore, it aims to shed light on the perceptions, attitudes, and behaviours of individuals with obesity in these countries. The ultimate goal of this study is to foster advocacy among healthcare providers, individuals with obesity, policy makers, and healthcare systems to effectively identify, prevent, and manage obesity in India, Pakistan, Philippines, and Vietnam. By doing so, it is anticipated that the study’s findings could potentially lead to improved public health outcomes and resource allocation in these countries.

This study aims to help build advocacy among healthcare professionals, people with obesity, policymakers, and healthcare systems to effectively identify, prevent, and manage obesity in these countries. The findings will provide valuable data to guide future healthcare policies and interventions.

Study involves only one visit per patient. Patients who are visiting the Clinic/hospital for their routine clinical care and meets the study criteria will be asked to participate in the study. Data will be collected after obtaining the consent.
 
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