| CTRI Number |
CTRI/2025/08/092697 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Education] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Effect of Nutrition Education program in increasing Knowledge of Nurses in a Hospital in Mumbai |
|
Scientific Title of Study
|
Impact of Nutrition Education Program on Enhancing Knowledge regarding Probiotics in Nurses in a Tertiary Care Hospital 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 |
Janhavi Patil |
| Designation |
Student |
| Affiliation |
Dr B M N 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
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9969942847 |
| Fax |
|
| Email |
janhavi31patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Sanwalka |
| Designation |
Associate Professor |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute.
Block V Lower Basement Jehangir Hospital,
32 Sassoon Road, Pune Station.
Pune 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
8108009900 |
| Fax |
|
| Email |
neha.sanwalka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Sanwalka |
| Designation |
Associate Professor |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute.
Block V Lower Basement Jehangir Hospital,
32 Sassoon Road, Pune Station.
Pune 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
8108009900 |
| Fax |
|
| Email |
neha.sanwalka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saint George Hospital,
P DMello Rd, opposite GPO, beside CST station, Chhatrapati Shivaji Terminus Area, Fort, Mumbai, Maharashtra, India
Pin Code- 400001 |
|
|
Primary Sponsor
|
| Name |
Janhavi Patil |
| Address |
Divya Rishi Appartment, 338, R.A. 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 Vidya Gupta |
Saint George Hospital, Mumbai |
P DMello Rd, opposite GPO, beside CST station, Chhatrapati Shivaji Terminus Area, Fort, Mumbai, Maharashtra 400001
Mumbai
MAHARASHTRA |
9867832245
drvidyagupta.73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no diseased condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline knowledge and attitude questions. |
Questions based on detailed knowledge about probiotics. |
| Intervention |
Nutrition Education Program (NEP) on Probiotics for Nurses |
The intervention involves a structured Nutrition Education Program (NEP) specifically designed to enhance knowledge and attitude regarding probiotics among registered nurses in a tertiary care hospital. The program includes a educational session. The content covers definitions, strain-specific probiotic benefits, food-based Indian sources, mechanisms of action, and practical applications in clinical settings. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Female |
| Details |
Female Nurses
Employed for more than 1 year |
|
| ExclusionCriteria |
| Details |
Doctors or other health care workers
Working for less than one year
Retired or male nurses |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will provide insights into the levels of knowledge, attitudes and practices of nurses towards probiotics
A positive shift in attitude and perception of probiotics, post intervention
Increases awareness among nurses about clinical relevance and dietary sources of probiotics
An ebook will be developed that can be used by nurses as a ready reckoner for probiotics. |
within 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/08/2025 |
| 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="9"
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 research proposal, titled “Impact of Nutrition Education Program on Enhancing Knowledge regarding Probiotics in Nurses in a Tertiary Care Hospital in Mumbai”, aims to evaluate the effectiveness of a structured Nutrition Education Program (NEP) in improving knowledge and attitudes regarding probiotics among nurses. The hypothesis is that targeted nutrition education can significantly enhance nurses’ understanding and perception of probiotics. The study will involve registered nurses from a tertiary care hospital in Mumbai, using a validated Knowledge, Attitude, and Practice (KAP) questionnaire administered before and after the intervention. The expected outcome is that a structured NEP will positively influence nurses’ probiotic-related knowledge and attitudes, strengthening their ability to provide evidence-based nutrition guidance in clinical practice. |