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CTRI Number  CTRI/2025/07/092081 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Impact of Exercise on Body Image and Self-Belief among Middle-Aged Women 
Scientific Title of Study   The Role of Physical Activity on Body Image and Self-Efficacy among Middle-Aged Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharvani V Bhat 
Designation  M.Sc. Clinical Psychology Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7019207934  
Fax    
Email  sharvani.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ms Indu Toby 
Designation  Assistant Professor - Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9482784595  
Fax    
Email  indu.toby@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ms Indu Toby 
Designation  Assistant Professor - Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal


KARNATAKA
576104
India 
Phone  9482784595  
Fax    
Email  indu.toby@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Sharvani V Bhat 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
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 Baskaran Chandrasekaran  Manipal College of Health Professions  Fifth Floor, Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA 
7639280751

baskaran.c@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  Individuals who are not: a) Presently under treatment for any medical conditions that limit the ability to engage in physical exercise; b) Presently under treatment for any psychiatric conditions  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women between the age range of 45-60 years (including 45 & 60 years) 
 
ExclusionCriteria 
Details  a) Presently under treatment for any medical conditions that limit the ability to
engage in physical exercise; b) Presently under treatment for any psychiatric conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Physical activity, body image and self-efficacy  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="176"
Sample Size from India="176" 
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)   11/08/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Aim: This study is aimed at understanding the relationship between physical activity, body image and self-efficacy among middle-aged women.


Objectives: To assess the levels of physical activity, body image perception and levels of self-efficacy among middle-aged women; Establish a potential relationship between physical activity, body image and self-efficacy among middle-aged women; To understand the possible covariates and other determinants mediating the relationship.


Justification for study: There is a clear need or this study as there is little research on the linkage between physical activity, body image and self-efficacy among middle-aged women. While existing research primarily examines hormonal changes and their effects on body image and exercise motivation, there is limited understanding of how these factors influence middle-aged women in other contexts. This study can aid to inform strategies to boost physical activity, enhance body image and build self-efficacy, improving overall health and quality of life. It also aligns with UN Sustainable Development Goals — a) Goal 3: Promotes good health and well-being by addressing the needs of an overlooked demographic and b) Goal 5: Advances gender equality by recognizing and addressing the unique experiences of middle-aged women. Findings from this study can lead to inclusive health programs and bridge gender gaps in health-related research.


Detailed description of procedure / processes: The study will be conducted at the Department of Clinical Psychology, Manipal College of Health Professions, Manipal academy of Higher Education, Manipal. Following the approval from the department, the protocol will be submitted to the Institutional Research Committee (IRC). Subsequently, the protocol will be then reviewed by the Institutional Ethics Committee (IEC), upon the clearance from the IEC, the required documents will be submitted to the CTRI. The participants who will be approached in this study will be middle-aged women belonging to the age group of 45 to 60. The data will be collected using questionnaires administered through the help of online platforms such as Google Forms. The data will be collected online, where the tester will circulate the forms online to those individuals belonging to the target group through social media platforms such as WhatsApp. After administrative approval, Flyers to promote the study will be put up with QR codes that lead to the survey, in organisations where there is a surge of middle-aged women participating such as Rotaract clubs, banks, etc. The questionnaire will consist of a concise overview of the study, followed by a section for the participants to fill in their informed consent. Once the participants give informed consent, the demographic details along with the responses to the questionnaire will be collected. The questionnaire can be completed in approximately 20 minutes, though there is no time limit imposed to complete the same. The respondents will be screened using the K-10 (Kessler et al., 2003) screening tool for severe distress. The questionnaires used are standardised and validated scales for the target demographic, namely the International Physical Activity Questionnaire (Craig C. L. et al., 2003), Body Shape Questionnaire – Short Form Version (Evans C. & Dolan B., 1993) and Generalised Self-Efficacy Scale (Schwarzer R. and Jerusalem M ,1995). From the responses collected, the respondents will be screened on the basis of the criteria of inclusion and exclusion, and only the responses of those who pass the criteria will be considered for further statistical analysis.


Data Analysis: Once the required responses are collected, the data from the same will be subjected to statistical analysis, carried out with the help of a statistician. The statistical results will then be analysed to test the hypothesis of the study.



 
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