| CTRI Number |
CTRI/2025/07/091534 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on How Lifestyle Habits Differ Between Women in Perimenopause and Postmenopause, Focusing on Diet, Sleep, Physical Activity, and Stress |
|
Scientific Title of Study
|
The Impact of Perimenopause and Postmenopause on Lifestyle Patterns: A Comparative Cross-Sectional Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanika Raut |
| Designation |
Student |
| Affiliation |
Dr. BMN College Of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics,338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019, India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8108140589 |
| Fax |
|
| Email |
sanikaraut38770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College Of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019, India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College Of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019, India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College Of Home Science |
|
|
Primary Sponsor
|
| Name |
Sanika Raut |
| Address |
338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-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 Lakshmi Menon |
Dr. BMN College Of Home Science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019, India
Mumbai
MAHARASHTRA |
9003072531
lakshmimenon@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with chronic conditions such as diabetes, hypertension, and thyroid disorders will also be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Women in perimenopause and postmenopause based on the STRAW 10+ criteria
2.Healthy perimenopausal and postmenopausal women 3.Perimenopausal and postmenopausal women with chronic conditions (Diabetes, Hypertension, Thyroid disorders)
|
|
| ExclusionCriteria |
| Details |
Women with severe illnesses, Women on hormone replacement therapy (HRT). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare lifestyle patterns, including dietary intake, physical activity, sleep quality, and stress levels, between perimenopausal and postmenopausal women to identify potential differences that may address the distinct needs of both groups to improve their well-being. |
Within 4 months of the study duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the macronutrient intake in perimenopausal and postmenopausal women by using 2 days 24 hour dietary recall.
2. To assess the intake of specific essential nutrients in perimenopausal and postmenopausal women through 24 hour dietary recall and Food Frequency Questionnaire.
3. To evaluate the physical activity levels in both groups by using International Physical Activity Questionnaire.
4. To evaluate sleep quality in both the groups by using the Pittsburgh sleep Quality Index.
5. To assess stress levels in both groups by using Perceived stress scale.
6. To compare the macronutrient and essential nutrient intake between perimenopausal and postmenopausal women
7. To compare the physical activity levels, sleep quality and stress levels between both the groups. |
Within 3-4 months of study duration. |
|
|
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)
|
05/08/2025 |
| 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 is a comparative cross-sectional, descriptive, and quantitative study designed to assess and compare lifestyle patterns among perimenopausal and postmenopausal women aged 40 to 60 years in the Mumbai Suburban region. The study aims to evaluate key lifestyle patterns including dietary intake, physical activity, sleep quality, and stress levels using validated tools such as a 2-day 24-hour dietary recall, Food Frequency Questionnaire, International Physical Activity Questionnaire , Pittsburgh Sleep Quality Index, and Perceived Stress Scale. A total of 200 participants will be selected through convenience sampling, with approximately equal representation from both menopausal groups. By identifying differences and similarities in these lifestyle patterns, The findings from this study will help future research to better understand the lifestyle needs of women in different menopausal phases and support the development of necessary interventions to enhance their overall health and quality of life. |