| 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
|
|
|
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
|
|
|
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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