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CTRI Number  CTRI/2023/11/060050 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 02/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Study The Relationship Between Physical Activity Levels And Body Composition Of Urban Young Adults Aged 18-25 Years. 
Scientific Title of Study   To Study the Relation Between Physical Activity Levels And Body Composition Of Urban Young Adults Aged 18-25 Years. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan Iqbal Merchant 
Designation  Student 
Affiliation  Dr. BMN College Of Home Science 
Address  Dr. BMN College Of Home Science 338, Rafi Ahmed kidwai Road, Matunga East, Mumbai, Maharashtra 400019

Mumbai
MAHARASHTRA
400019
India 
Phone  9987542622  
Fax    
Email  merchantmuskan13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amrita Behel 
Designation  Professor 
Affiliation  SNDT womens college 
Address  Cama Lane, Ratan Baug, Cama Lane, Ghatkopar West,, , , Ghatkopar West, Mumbai

Mumbai
MAHARASHTRA
400086
India 
Phone  9869361456  
Fax    
Email  amritabehel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amrita Behel 
Designation  Professor 
Affiliation  SNDT womens college 
Address  Cama Lane, Ratan Baug, Cama Lane, Ghatkopar West,, , , Ghatkopar West, Mumbai

Mumbai
MAHARASHTRA
400086
India 
Phone  9869361456  
Fax    
Email  amritabehel@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Muskan Iqbal Merchant 
Address  Dr. BMN College Of Home Science 338, Rafi Ahmed kidwai Road, Matunga East, Mumbai, Maharashtra 400019 
Type of Sponsor  Other [Self Sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Merchant Muskan Iqbal  Dr BMN College Of Home Science  338, Rafi Ahmed Kidwai Road, Matunga east, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 
9987542622

merchantmuskan13@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Societies Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Apparently healthy young adults including both girls and boys.
Residents of Mumbai Metropolitan Region Participants should belong to age group between 18-25years
Eligible individuals consenting to participate in the study.

 
 
ExclusionCriteria 
Details  Individuals suffering from any disease condition.
Children or adults <18 and >25 years of age.
Individuals who refuse to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Physical activity levels and resulting effects on body composition have a profound influence on future health outcomes of population groups. Young adults are primary contributors to national development and therefore their health remains a priority. Comprehensive guidelines for modifying physical activity habits will contribute to better future health to ensure healthier habits will contribute to better future health to ensure healthier populations which are essential for better prognostic health outcomes.   Baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Aim : to study the composition using anthropometric measurements of young adults aged between 18-25 years residing in the Mumbai Metropolitan Region (MMR).

Objectives :
1. To assess body composition using anthropometric measurements of young adults aged between 18-25 years residing in the Mumbai Metropolitan region (MMR).
2. To assess the physical activity levels of the study population. 
3. To study the association between body composition and physical activity levels of the study population. 

Materials & Method :
Research Type & Study Design : Descriptive Cross-sectional study
Sampling Technique : Purposive Convenience sampling Method
Sample size : 150 young adults

 
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