| CTRI Number |
CTRI/2025/08/093122 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
"An Online Learning Program to Promote Mindful Eating Habits in Teenagers" |
|
Scientific Title of Study
|
Development of a Self-Learning Module on Mindful Eating Practices and Assessing Its Impact on Eating Behaviors Among Adults Aged 15 -17 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 |
Urmi Nitin Patil |
| Designation |
Post Graduation M.Sc CND |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Parijat Bunglow Near Holi Maidan Naringi Virar West
Thane
MAHARASHTRA
401303
India |
| Phone |
8983123882 |
| Fax |
|
| Email |
urminpatil8882@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
Smt. Maniben M.P.Shah Women’s College of Arts & Commerce (Autonomous), Matunga, Mumbai-19 |
| Address |
Smt. Maniben M.P.Shah Women’s College of Arts & Commerce (Autonomous), Matunga, Mumbai-19
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MADHAVI SATHE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Smt. Maniben M.P.Shah Women’s College of Arts & Commerce (Autonomous), Matunga, Mumbai-19 |
| Address |
Smt. Maniben M.P.Shah Women’s College of Arts & Commerce (Autonomous), Matunga, Mumbai-19
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science (Empowered Autonomous Status)Divya Rishi Apartment, 338, R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Urmi Patil |
| Address |
Parijat Bunglow Near Holi Maidan Naringi Virar West |
| 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 Madhavi Sathe |
College |
Dr. BMN College of Home Science And VIVA College
Mumbai
MAHARASHTRA |
9892544080
misathe@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 |
dietary awareness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
adolescents |
15-17 years age duration 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Students aged 15–17 years.
Enrolled in Dr. BMN College and Viva College.
Access to mobile devices or internet for feedback submission.
Willing to complete offline module tasks. |
|
| ExclusionCriteria |
| Details |
Students currently practicing mindfulness techniques regularly.
Students undergoing treatment for obesity or metabolic disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in mindful eating scores
Reduction in emotional eating behavior
Improved portion control and food choices
|
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants feedback on learning experience |
24 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)
|
01/08/2026 |
| 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="3"
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
|
The present study titled “Development of a Self-Learning Module on Mindful Eating Practices and Assessing Its Impact on Eating Behavior among Adults Aged 15–17 Years” aims to design, implement, and evaluate a self-learning educational module that promotes mindful eating practices among adolescents. The intervention will be conducted on participants aged 15–17 years, who will be assessed for their eating behaviors before and after exposure to the module. The study will use validated tools to measure outcomes related to mindful eating awareness and behavioral changes. This is a non-drug, educational, interventional study approved by the Institutional Ethics Committee. The findings will contribute to preventive health education and behavioral nutrition among adolescents. |