| CTRI Number |
CTRI/2024/03/063634 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Compare the Sleep Quality Among Day Snacks versus Night Snacks Consuming Young Adult Females Living in Mumbai. |
|
Scientific Title of Study
|
Comparison of Sleep Quality between Day Snack vs Night Snack
consuming young adult females. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ansari Laiba kaosar Ghulam Moinuddin |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338,Rafi Ahmed Kidwai Rd, Matunga East, Mimbai, Maharashtra 400019
Mumbai
MAHARASHTRA
4100019
India |
| Phone |
9022088633 |
| Fax |
|
| Email |
laibaansari10302@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, Mimbai, Maharashtra 400019
Mumbai
MAHARASHTRA
4100019
India |
| Phone |
9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Ansari Laiba kaosar Ghulam Moinuddin |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338,Rafi Ahmed Kidwai Rd, Matunga East, Mimbai, Maharashtra 400019
Mumbai
MAHARASHTRA
4100019
India |
| Phone |
9022088633 |
| Fax |
|
| Email |
laibaansari10302@gmail.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 |
Ansari Laiba Kaosar Ghulam Moinuddin |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 4100019 |
| 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 |
| Dr Harsha Chopra |
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 |
9969810104
harshachopra@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 |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1- Young Adult Females aged 18-24 years residing in Mumbai.
2- Voluntarily agrees to participate in the study.
3- Not suffering from any known disease.
4- Residing in Mumbai. |
|
| ExclusionCriteria |
| Details |
1- Individuals from nutritional backgrounds.
2- Any Male Participants.
3- Suffering from any known disease or eating disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Night snack consumption will affect the sleep quality and nutritional status among young adults.
This study will help in understanding the association of time of snack consumption with sleep quality . |
6 Months |
|
|
Secondary Outcome
|
|
|
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)
|
12/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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
|
Aims & Objectives:
Aim: To Compare the Sleep Quality among Day Snack and Night
Snack consuming Young Adult females living in Mumbai.
Objective:
1-To assess snacking habits of Young Adult females aged
18-24 years living in Mumbai.
2-To assess and compare the dietary intakes between the day
snackers and night snackers.
3-To check the association of snack consumption with sleep
quality in day and night snack consuming females.
Null Hypothesis: There is no difference in Sleep Quality and
Nutritional Status between Day Snack vs Night Snack consuming young adult
females
|