| CTRI Number |
CTRI/2025/08/093618 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Printed Information on Food Packages to Promote Healthier Food Choices Among School-Going Children |
|
Scientific Title of Study
|
EFFECTIVENESS OF FOOD LABEL INFORMATION PROGRAMME (FLIP) TO MAKE HEALTHIER FOOD CHOICES AMONG SCHOOL GOING CHILDRENS IN TRIBAL PREDOMINANT DEOGHAR DISTRICT, JHARKHAND, INDIA: A MIXED METHODS STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vasanth c |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
All India Institute of Medical Sciences College of Nursing |
| Address |
Academic Block 3rd floor
All India Institute of Medical sciences College of Nursing AIIMS Deoghar
Deoghar
JHARKHAND
814152
India |
| Phone |
9006248830 |
| Fax |
|
| Email |
vasanth.nur@aiimsdeoghar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
vasanth c |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
All India Institute of Medical Sciences College of Nursing |
| Address |
Academic Block 3rd floor
All India Institute of Medical sciences College of Nursing AIIMS Deoghar
Deoghar
JHARKHAND
814152
India |
| Phone |
9006248830 |
| Fax |
|
| Email |
vasanth.nur@aiimsdeoghar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
vasanth c |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
All India Institute of Medical Sciences College of Nursing |
| Address |
Academic Block 3rd floor
All India Institute of Medical sciences College of Nursing AIIMS Deoghar
Deoghar
JHARKHAND
814152
India |
| Phone |
9006248830 |
| Fax |
|
| Email |
vasanth.nur@aiimsdeoghar.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences Deoghar |
| Address |
All India Institute of Medical sciences COLLEGE OF NURSING ACADEMIC BLOCK 3RD FLOOR DEVIPUR DEOGHAR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VASANTH C |
Five Government Secondary Schools |
Deoghar, Jharkhand, India
Deoghar
JHARKHAND |
9006248830
0
vasanth.nur@aiimsdeoghar.edu.in |
| VASANTH C |
Five Private Secondary Schools |
Deoghar, Jharkhand, India
Deoghar
JHARKHAND |
9006248830
vasanth.nur@aiimsdeoghar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS DEOGHAR |
Approved |
| SCHOOLS OF DEOGHAR |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Food Label Information Programme |
There will be intervention given to the experimental group regarding food labels in terms of assessing their knowledge, attitude, and practice. At first, a pretest will be conducted, followed by a post-test with intervention. Secondly, for the qualitative part, an unstructured questionnaire will be used to analyse the qualitative data with audiotape and will be transcribed verbatim to the intervention group. |
| Comparator Agent |
NO HEALTH EDUCATION |
There will be no intervention given to the control group regarding food labels in terms of assessing their knowledge, attitude, and practice. At first, a pretest will be conducted, followed by post test without intervention |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Both genders, along with transgender, will be included in the study.
2. Those who are studying in 8th 9th 10th standard
3. Those who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. The students who have already attended any form of food label Information programme.
2. Children who are sick during the time of intervention and data collection.
3. Children under special diet or modified diet, medical advice, or nutritional instruction regarding food habits.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the Food Label Information Programme (FLIP) in making healthier food choices in terms of knowledge, attitude, and practice among school-students between the experimental and control group. |
Two time points (baseline and endline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the school student’s perception regarding the food label information |
endline |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
10/09/2025 |
| 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="6"
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 randomised control trial assesses the effectiveness of a food label information program in terms of knowledge, attitude, and practice between the experimental and control groups. Though this is a mixed-method study , it has quantitative and qualitative parts. the quantitative assessed with pre-test followed by an intervetion, and post test will be conducted the both group the control group routine education. research design will be a true experimental two-arm design with multistage cluster sampling. The qualitative part will be carried out with a focus group discussion until data saturation. Total sample size: 500 (250+250). This study will be conducted at the secondary school in Deoghar. H1: there will be no significant difference between the pre- and post test of KAP H2: There will be no significant correlation between the level of the group. H3: There will be no significant association between the level of knowledge and practice. |