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CTRI Number  CTRI/2024/02/063383 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Health and Wellbeing in Indias Transgender Community: A Study of Anthropometric Measures and Quality of Life 
Scientific Title of Study   To evaluate, interpret and standardize the normative data value of various anthropometric measures and quality of life (QOL) among gender incongruent individuals from Transgender community of India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Badri Vishal 
Designation  PhD Scholar 
Affiliation  Santosh Deemed to be University 
Address  Department of Orthopaedics, Santosh Deemed to be University, No. 1., Sector 12, Santosh Nagar, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  7838792442  
Fax    
Email  dr.badri378@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr.) Deepak Raghav 
Designation  Guide, Principal, Santosh college of Physiotherapy 
Affiliation  Santosh Deemed to be University 
Address  Department of Physiotherapy, Santosh Deemed to be University, No. 1., Sector 12, Santosh Nagar, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9868315824  
Fax    
Email  deepak.raghav@santosh.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. Badri Vishal 
Designation  PhD Scholar 
Affiliation  Santosh Deemed to be University 
Address  Department of Orthopaedics, Santosh Deemed to be University, No. 1., Sector 12, Santosh Nagar, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  7838792442  
Fax    
Email  dr.badri378@gmail.com  
 
Source of Monetary or Material Support  
Santosh Deemed to be University 
 
Primary Sponsor  
Name  Dr Badri Vishal 
Address  Department of Orthopaedics, Santosh Deemed to be University, No. 1., Sector 12, Santosh Nagar, Pratap Vihar, Ghaziabad, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Badri Vishal  Santosh Deemed to be University  Basement 1, Department of Physiotherapy, Santosh Deemed to be University, No. 1., Sector 12, Santosh Nagar, Pratap Vihar, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH 		 7838792442

dr.badri378@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Advisory Committee (RAC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Transgenders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIl 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Transgender by birth. Dwelling in the community of Transgenders. 
 
ExclusionCriteria 
Details  Individuals will be excluded from the study if they have an inability to respond to, or an unwillingness to participate in the study or suffering from severe psychiatric disorders or any limiting chronic disease or DSD. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SF – 36 to be used for Quality-of-Life Indication.
2. Body composition - Lean body mass, Body Fat%
4. Muscle mass
5. Muscle strength - Grip strength, Pinch Grip, Leg and Back Strength
6. Girth Measurement - Thigh, Upper Arm, Forearm, Pelvic width relative to pelvis height
7. VO2max
8. 6MWT
9. Step Test
10. Borg Ratings of Perceived Exertion.
11. Reaction Time - Simple Reaction Time, Choice Reaction Time. 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
The surveys of Healthcare Workers, trainees and students will comprise of
1. General demographic questionnaire
2. Awareness of Transgender Topics Measure (ATTM)
3. Anti-Transgender Prejudice Scale (ATP).
 		 6 Months 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.badri378@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The data collection process starts after making sure all participants met all of inclusion and exclusion criteria for the study. After obtaining written informed consent from all the voluntary participants from Transgenders community, a detailed history regarding the socio-demographic data will be recorded using a semi-structured format and all the data will be recorded individually. 
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