| CTRI Number |
CTRI/2025/07/091705 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Education Program ] |
| Study Design |
Other |
|
Public Title of Study
|
- "Overcoming Language Barriers in Nutrition Education for Teenagers"
|
|
Scientific Title of Study
|
Overcoming Language Barrier for Fruit and Vegetable Nutrition Education for School-Going Children (13-15 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 |
Dipti Suryavanshi |
| Designation |
Student MSc. Clinical Nutrition and Dietetics |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr BMN College of Home Science
Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
09833091913 |
| Fax |
|
| Email |
suryavanshidipti2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monal Velangi |
| Designation |
Sr. Dietitian |
| Affiliation |
Institute K J Somaiya hospital and research centre |
| Address |
2nd floor, Chere View, L.N. road, Dadar East Mumbai 400014.
Mumbai (Suburban)
MAHARASHTRA
400014
India |
| Phone |
09136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monal Velangi |
| Designation |
Sr. Dietitian |
| Affiliation |
Institute K J Somaiya hospital and research centre |
| Address |
2nd floor, Chere View, L.N. road, Dadar East Mumbai 400014.
Mumbai (Suburban)
MAHARASHTRA
400014
India |
| Phone |
09136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dipti Suryavanshi |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 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 |
| Shailendra Kadam |
Nutan Vidya Mandir |
Mankhurd, Near SPDC Colony, Sion Trombay Road, Deonar, Mumbai, Maharashtra 400088, India
Mumbai (Suburban)
MAHARASHTRA |
9869739777
-
suryavanshidipti2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Seva Mandal Education Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
13-15-year-old adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline Questionnaire |
KAP about the fruits and vegetables and |
| Intervention |
Nutrition Education Program |
providing benefits and the importance of fruits and vegetables for school-going children through games and workshops
This process will be completed within 3 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
Students enrolled in grades seven to ninth
Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
Students with pre-existing dietary restrictions due to medical conditions
Those unwilling to participate or unable to provide consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved awareness and knowledge about healthy eating habits
2. Increased frequency of fruit and vegetable consumption post-intervention
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increased frequency of fruit & vegetable consumption post intervention
|
6 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)
|
20/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
TITLE Overcoming Language Barrier for Fruit and Vegetable Nutrition Education for School-Going Children (13-15 years) AIM To develop and evaluate the impact of a nutrition education program on school-going children (13-15 years) OBJECTIVES: To understand the fruit and vegetable consumption patterns of the participants. To develop a fruit and vegetable nutrition education intervention program. To study the effect of the fruit and vegetable nutrition education intervention program HYPOTHESIS Null Hypothesis The nutrition education intervention has no significant impact on the frequency of fruit and vegetable consumption or dietary awareness among school adolescents. |