| CTRI Number |
CTRI/2025/08/092878 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Does eating habits and exercise affect period health in young women |
|
Scientific Title of Study
|
A Study on the Association Between Diet Diversity, Physical Activity and Menstrual Health of 18–25-year-old 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 |
Uzma Khan |
| Designation |
Student |
| Affiliation |
Dr. BMN COLLEGE OF HOME SCIENCE |
| Address |
Dr BMN College of Home Science Divya Rishi Apartment 338 RA Kidwai Road Matunga Mumbai Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
8689984426 |
| Fax |
|
| Email |
uzmask1602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant professor |
| Affiliation |
Smt PN Womens College |
| Address |
Smt PN Womens College Ghatkopar West Mumbai 400086
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant professor |
| Affiliation |
Smt.PN Womens College |
| Address |
Smt PN Womens College Ghatkopar West Mumbai 400086
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN COLLEGE OF HOME SCIENCE, DEPARTMENT OF CLINICAL NUTRITION AND DIETETICS, 338 R.A. KIDWAI MARG, MATUNGA EAST, MUMBAI, MAHARASHTRA 400019 |
|
|
Primary Sponsor
|
| Name |
Uzma Khan |
| Address |
Dr BMN College of Home Science, Divya Rishi Apartment 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra 400019 |
| 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 Rupali Sengupta |
Dr. BMN College Of Home Science |
Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment 338 R A Kidwai Marg Matunga East 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUCATIONAL SOCIETY INSTITUTIONAL EHTICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INDIVIDUALS WITH NO DISEASE CONDITIONS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18-25 years.
2. Regular menstrual cycles (at least 3 cycles before data collection).
3. Willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding women.
2. Women with severe gynaecological conditions like endometriosis or fibroids requiring medical intervention.
3. Women using hormonal contraceptives.
4. Individuals with known eating disorders or chronic illness affecting dietary intake.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the association between diet variety, physical activity, and menstrual health outcomes among reproductive-aged women. |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Establish an association between diet diversity, physical activity & improved menstrual health
|
5 weeks |
| identify dietary targets that may benefit menstrual health |
6 weeks |
| gain better understanding of how both diet diversity & physical activity affect menstrual health |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
22/08/2025 |
| 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="0"
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
|
This cross-sectional observational study aims to examine the interplay between diet diversity, physical activity and menstrual well-being in 18-25-year-old women. The research objective includes assessing the level of diet diversity, investigating its relationship with menstrual health and identifying specific food groups or dietary components that may influence menstrual health. Data collection will involve a demographic and lifestyle questionnaire , a food frequency questionnaire, menstrual distress syndrome, premenstrual syndrome questionnaire and international physical activity questionnaire. While there are no findings yet, the expected outcomes include establishing an association between diet diversity, physical activity and improved menstrual health, identifying dietary targets for menstrual well-being. |