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CTRI Number  CTRI/2024/11/076333 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Looking into the relationship between feeling of the body and physical activity level among adults between 18 to 30 years 
Scientific Title of Study   Relationship between body image and physical activity among young adults- A Correlation study 
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 Vaishali K 
Designation  Professor 
Affiliation  Manipal College of Health Professions / Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9353039762  
Fax    
Email  vaishali.kh@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mudaliar Indiraa B. 
Designation  Intern 
Affiliation  Manipal College of Health Professions / Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Same as Address 1
Udupi
KARNATAKA
576104
India 
Phone  9353039762  
Fax    
Email  mudaliar.balasubramanian@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali K 
Designation  Professor 
Affiliation  Manipal College of Health Professions / Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal


KARNATAKA
576104
India 
Phone  9353039762  
Fax    
Email  vaishali.kh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104 
 
Primary Sponsor  
Name  Department of Physiotherapy Manipal College of Health Professions 
Address  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, 576104  
Type of Sponsor  Research institution and hospital 
 
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 Vaishali K  Kasturba Hospital  Cardiopulmonary Exercise Laboratory, Department of Physiotherapy, Kasturba Hospital, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA 		 9353039762

vaishali.kh@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young adults between the age of 18-30 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Free from musculoskeletal injuries, fractures, and neurological disorders
Willing to participate in the study. 
 
ExclusionCriteria 
Details  Individuals undergoing treatment for mental health disorders, and eating disorders.
Difficulty in hearing and comprehending information.
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Body Image
2 Physical activity 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1 Self esteem
2 Eating disorder 		 Baseline 
 
Target Sample Size   Total Sample Size="316"
Sample Size from India="316" 
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)   02/12/2024 
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="1"
Months="0"
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 - NO
Brief Summary   The protocol for the research project will be submitted to the Institutional Research Committee (IRC), MCHP, MAHE. On receiving approval from IRC, ethical clearance for the study will be obtained from the Institutional Ethics Committee (IEC), KMC, MAHE. The study will then be registered under the Clinical Trials Registry of India (CTRI). Participants will be recruited by displaying advertisements for the project on Manipal College of Health Professions noticeboards after obtaining authorization from the Dean and in social media groups. They will be assessed for eligibility requirements, and those who meet the criteria will be accepted into the study. The method for the study will be outlined by providing a participant information sheet and written informed consent will be obtained. Demographic details for all the recruited participants will be taken and then the participants will undergo baseline assessment for body impedance analysis and fill out the outcome measures including BSQ-16, GPAQ, RSEQ, and EAT-26. Data will be collected and analyzed. The total time required for data collection will be 20 minutes. 
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