| CTRI Number |
CTRI/2025/01/079232 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Linking nutrition with sleep quality of schoolgoing girls (14-17 years old). |
|
Scientific Title of Study
|
Association of nutrition with sleep quality of middle-adolescent girls (14-17 years old). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arena Kamlesh Jain |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai 400019, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
8433660531 |
| Fax |
|
| Email |
arenajain11@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, Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai 400019, Maharashtra, India
Mumbai (Suburban)
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, Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai 400019, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019 Mumbai Maharashtra |
|
|
Primary Sponsor
|
| Name |
Arena Kamlesh Jain |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Road, 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 |
| Dr Lakshmi Menon |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science, Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai 400019, Maharashtra, India
Mumbai (Suburban)
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 |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
Studying in Schools in Byculla. |
|
| ExclusionCriteria |
| Details |
Having any diseases like diabetes, hepatitis and any other metabolic disorders.
Any medications other than vitamin and mineral supplements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The desired outcome is to gain an understanding of the nutritional status, dietary intake and assess their sleep quality and establish a relationship between dietary intake and sleep quality. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The desired outcome is to gain an understanding of the nutritional status, dietary intake & assess their sleep quality & establish a relationship between dietary intake & sleep quality. |
4 months |
|
|
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)
|
31/01/2025 |
| 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="10"
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
|
1. To understand the demographic profile (age and socio-economic status). 2. To assess the nutritional status of middle adolescents. 3. To evaluate dietary intakes of middle adolescents using a 3 - Day food diary and Food Frequency Questionnaire. 4. To evaluate the sleep quality of middle adolescents using the Pittsburgh Sleep Quality Index. 5. To understand the association between dietary intake and sleep quality. |