| CTRI Number |
CTRI/2025/08/093254 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of lifestyle factors and body composition on menstrual regularity in adolescents |
|
Scientific Title of Study
|
Is adolescent menstrual regularity influenced by lifestyle factors and body composition |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gangubai Devaramani |
| Designation |
postgraduate student |
| Affiliation |
Sdm college of physiotherapy dharwad |
| Address |
SDM college of medical sciences and hospital SDM university community Physiotherapy Department 1st floor old building opd nor 13 sdm college of physiotherapy sdm university sattur dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7676734015 |
| Fax |
|
| Email |
gangubai2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha Bhatbolan |
| Designation |
Associate professor |
| Affiliation |
sdm college of physiotherapy dharwad |
| Address |
SDM college of physiotherapy and hospital sdm university obg department 1st floor old building opd nor 13 sdm college of physiotherapy sdm university sattur dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9916067268 |
| Fax |
|
| Email |
shweta.bhatbolan@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gangubai devaramani |
| Designation |
postgraduate student |
| Affiliation |
sdm college of physiotherapy dharwad |
| Address |
SDM college of medical sciences and hospital SDM university community Physiotherapy Department 1st floor old building opd no 13 sdm college of physiotherapy sdm university sattur dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7676734015 |
| Fax |
|
| Email |
gangubai2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded and data collected from other college with permission |
|
|
Primary Sponsor
|
| Name |
Gangubai devaramani |
| Address |
SDM college of medicalsciences and hospital manjushree nagar sattur dharwad 580009 |
| 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 |
| Gangubai Devaramani |
SDM University Dharwad And JSS PU College Dharwad |
SDM UNIVERSITY
SDM College of physiotherapy
SDM college of Nursing science
SDM college of dental sciences
SDM College of Medical sciences
SDM College of Pharmaceutical science
SDM Coleege of RIBS
SDM College Of Audiology and Speech language pathologies
,Sattur,karnataka,Dharwad 580009 and JSS PU College vidyagiri dharwad karnataka 580004
Dharwad
KARNATAKA |
7676734015
gangubai2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College Of Medical Sciences And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1 Adolescent women aged 17-19 years
2 Adolescent women who have experienced
menarche
3 Those willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Primary amenorrhea
2 Known genetic conditions that impact menstrual
health
Turners syndrome
Congenital adrenal hyperplasia
Kallman syndrome
Fragile X prematuration
Swayer syndrome
3 Cognitive or communication impairments
4 Lack of willingness or consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1SLIQ
2 Karada scan
3 Semi structured Menstrual regularity questionnaires |
pre awareness (baseline)
post awareness (after session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="322"
Sample Size from India="322"
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)
|
01/09/2025 |
| 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="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 proposed study explores the influence of lifestyle habits and body composition on menstrual regularity among adolescent girls aged 17 to19 recognizing adolescence as a crucial phase marked by physical and hormonal changes where menstruation serves as a key indicator of reproductive and overall health Despite its significance menstrual health is often neglected, especially in developing regions, leading to untreated irregularities and potential long-term health issues. Lifestyle factors such as poor diet, physical inactivity, stress, and obesity are known contributors, yet comprehensive research connecting these factors collectively to menstrual irregularities in adolescents remains limited. This cross-sectional study, conducted among 322 participants from SDM University and JSS PUC College using purposive sampling, will assess menstrual patterns, lifestyle behaviors using the SLIQ questionnaire, and body composition via Karada Scan It also includes an educational session to evaluate and enhance awareness of menstrual health. The expected outcomes include identifying modifiable lifestyle risks, enabling early interventions and empowering adolescent girls with the knowledge to manage their menstrual health ultimately contributing to reduced reproductive health complications and supporting the development of school based health awareness programs |