| CTRI Number |
CTRI/2024/11/076675 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the Effectiveness Of Lifestyle Modification Package on Polycystic Ovarian Syndrome in Terms of Knowledge, Lifestyle Practices and Clinical Parameters Among Girls at Selected Colleges, U.P. |
|
Scientific Title of Study
|
A study to evaluate the Effectiveness Of Lifestyle Modification Package on Polycystic Ovarian Syndrome in Terms of Knowledge, Lifestyle Practices and Clinical Parameters Among Girls at Selected Colleges, U.P. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemalatha M |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Moradabad, Uttarpradesh |
| Address |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Delhi Road, Moradabad, Uttarpradesh, 244001
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Delhi Road, Moradabad, Uttarpradesh, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7060899277 |
| Fax |
|
| Email |
diajohn2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Sharma |
| Designation |
Professor |
| Affiliation |
TMU |
| Address |
Teerthanker Mahaveer University
Moradabad, Uttarpradesh
Teerthanker Mahaveer University
Moradabad, Uttarpradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8377940075 |
| Fax |
|
| Email |
poonam14aug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemalatha M |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Moradabad, Uttarpradesh |
| Address |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Delhi Road, Moradabad, Uttarpradesh, 244001
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, Delhi Road, Moradabad, Uttarpradesh, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7060899277 |
| Fax |
|
| Email |
diajohn2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Road, Mantola, Agra, Uttarpradesh, 282001 |
|
|
Primary Sponsor
|
| Name |
Hemalatha M |
| Address |
Hemalatha,6/12/Chottapanikan Therivilai, KanyakumariTamil Nadu |
| 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 |
| HemalathaM |
Agra College, Agra (institute to conduct study) |
Multipurpose hall, Bachelor of science.
Agra
UTTAR PRADESH |
7060899277
0
diajohn2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMU-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Risk for Polycystic ovarean syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle modification package on Polycystic Ovarian Syndrome |
In this study, it refers to a comprehensive programme which includes education (all the aspects of PCOS, Risk factors and the pathophysiological changes etc) dietary pattern and exercise interventions using PPTs, videos, pamphlets related to PCOS which reduces the risk of poly cystic ovarian syndrome. The study duration would be 24 weeks. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
- Girls who are at risk of developing PCOS.
- Girls who are young adults aged between 18 to 22 years and studying in selected degree colleges
- Girls who are willing to participate.
- Girls who are available at the time of data collection.
- Girls who are able to read and understand English.
|
|
| ExclusionCriteria |
| Details |
- Girls who are not interested.
- Girls who are already exposed to an interventional programme
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - The interventional package will improve the knowledge, make a positive change in their health and improves their quality of life and improves practice, reduces acne,hirsuitism and maintain BMI to normal. |
24 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2024 |
| Date of Study Completion (India) |
02/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
With increasing numbers of PCOS at younger age there
is an increased risk for long‑term and/or late effects on the health, so
efforts for promoting the healthy lifestyle of this group are urgently needed.
So the
researcher felt to implement the lifestyle modification package among young
adult girls. This will provide valuable interventions relating to the
development of healthy lifestyle for PCOS and result in appropriate change in knowledge on Polycystic Ovarian Syndrome, life style, practice, physical symptoms and improve the quality of life.
|