| CTRI Number |
CTRI/2024/01/061908 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Relationship Between Sleep, Dietary Patterns, and Physical Activity Among Women Aged 30-40 Years in Mumbai |
|
Scientific Title of Study
|
Association of sleep (quality and duration) with dietary pattern and physical activity in women aged 30-40 years residing in Mumbai. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANDALIB FATIMA KHAN |
| Designation |
STUDENT |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8080337869 |
| Fax |
|
| Email |
khanandalibfatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HARSHA CHOPRA |
| Designation |
PROFESSOR |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HARSHA CHOPRA |
| Designation |
PROFESSOR |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India
MAHARASHTRA
400019
India |
| Phone |
9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science, Matunga, Department of postgraduate studies in clinical nutrition and dietetics, Mumbai |
|
|
Primary Sponsor
|
| Name |
ANDALIB FATIMA KHAN |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019 |
| Type of Sponsor |
Other [[SELF SPONSORED]] |
|
|
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 |
| ANDALIB FATIMA KHAN |
Dr. BMN College of Home Science |
Department of Post graduate studies in clinical nutrition and dietetics, Matunga East, Mumbai, Maharashtra 400019
Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA |
8080337869
khanandalibfatima@gmail.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 |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 30– 40 years
2. Women who are housewives and not working.
3. Women live in Mumbai.
4. Women not suffering from any disease.
5. Voluntarily agrees to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Women less than 30 years.
2. Women more than 40 years.
3. Working women and staying out of the suburbs of Mumbai.
4. Women who are pregnant, lactating, or menopausal. Women suffering from known diseases such as Hypertension, Diabetes, CVD, thyroid and others.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will help to understand the impact of poor sleep on diet, and physical activity and the importance of a regular sleep pattern and will help advocate a regular sleep pattern which will improve healthy eating, and physical activity.
|
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/01/2024 |
| 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 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
|
Aim:
To investigate the association of
sleep (quality and duration) with dietary patterns and physical activity in
women aged 30-40 years residing in Mumbai. Objective: 1.To
assess the sleep quality and duration in women aged 30 to 40 years. 2. To
examine their dietary pattern. 3. To
study the association of sleep quality, duration, with, dietary patterns and physical activity in middle-aged women.
|