| CTRI Number |
CTRI/2025/07/091784 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pre-Post Intervention] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Sleep-Wake Cycle, Dietary Patterns, Sleep Quality and Lifestyle of Adults Aged 25 to 45 Years |
|
Scientific Title of Study
|
Circadian Health, Dietary patterns and Lifestyle of Adults Aged 25 to 45 Years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishita Sirodariya |
| Designation |
Student |
| Affiliation |
Dr. B.M.N. College of Home Science |
| Address |
Dr BMN College of Home Science
Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9867063877 |
| Fax |
|
| Email |
sirodariya.nishita27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monal Velangi |
| Designation |
Sr. Dietitian |
| Affiliation |
K J Somaiya hospital and research centre |
| Address |
2nd floor, Chere View, L.N. road, Dadar East Mumbai
Mumbai
MAHARASHTRA
400014
India |
| Phone |
9136097274 |
| Fax |
|
| Email |
drmonalvelangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monal Velangi |
| Designation |
Sr. Dietitian |
| Affiliation |
K J Somaiya hospital and research centre |
| Address |
2nd floor, Chere View, L.N. road, Dadar East Mumbai
Mumbai
MAHARASHTRA
400014
India |
| Phone |
9136097274 |
| Fax |
|
| Email |
drmonalvelangi@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 |
Nishita Sirodariya |
| Address |
Dr BMN College of Home Science Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| 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 |
98924 15789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva mandal educational society institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having fixed work schedule |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutritional Education Program |
To provide Nutrition Education on circadian rhythm, dietary pattern, sleep quality and lifestyle using educational for a duration of 3 months. |
| Comparator Agent |
Pre intervention Questionnaire |
MEQ, PSQI, FFQ Scores of participants before intervention will provide baseline knowledge of participants |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Both working males and females
Aged between 25 to 45 years
Individuals with consistent work schedule (not working in different shifts)
|
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with sleep disorders
Individuals currently on any sleep related medications.
Individuals working in different shifts or having erotic work schedules.
Mental health issues.
Severe catabolic health problems – TB, Cancer etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced knowledge and behavioural improvement regarding circadian rhythm. |
10 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved diet pattern as reflected in FFQ scores. |
5 weeks |
| Improvement in sleep quality scores measured by PSQI post-intervention. |
6 weeks |
| Positive participant feedback on utilisation of education tools. |
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)
|
10/08/2025 |
| 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="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
|
This Pre-post Intervention study aims to
investigate the effects of a Nutrition Education Program (NEP) on the dietary
and lifestyle habits of working adults between the ages of 25 and 45. The study will be conducted among 200 participants using purposive convenience sampling. Data will be collected using validated tools including Morningness-Eveningness
Questionnaire (MEQ) for circadian rhythm, Pittsburgh Sleep Quality Index (PSQI) sleep assessment along with Food
Frequency Questionnaire (FFQ). The findings of the study may provide improved sleep quality and better dietary habits among participants who recieved nutritional educational program. |