| CTRI Number |
CTRI/2024/05/067826 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health education ] |
| Study Design |
Other |
|
Public Title of Study
|
To know if teaching adolescents in rural areas of Delhi about food labels can make a difference in what they know, how they feel, and what they do when it comes to using food label information. |
|
Scientific Title of Study
|
Effectiveness of educational intervention on knowledge, attitude and practice regarding usage of food label information among adolescents in rural area of Delhi |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Marotrao Narote |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of community medicine 3rd floor pathology block Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9130132148 |
| Fax |
|
| Email |
smnarote97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of community medicine Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8820404084 |
| Fax |
|
| Email |
doc.shweta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Marotrao Narote |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of community medicine 3rd floor pathology block Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9130132148 |
| Fax |
|
| Email |
smnarote97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College Campus
2 Bahadur Shah Zafar Marg near Delhi Gate
Balmiki Basti New Delhi Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Swati Marotrao Narote |
Rural Health Training Centre Barwala |
Health centre Barwala Sector 35 Rohini Delhi 110039
North West
DELHI |
9130132148
smnarote97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital Institutional Ethics Committee |
Approved |
| Maulana Azad Medical College and Associated Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent aged 14 to 19 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health education regarding food label knowledge |
Teaching adolescents in rural areas of Delhi about food label information about how to read how to analyse information to make healthier food choices |
| Comparator Agent |
Same group of study participants |
Knowledge attitude and practices of same group of participants will be assessed after health education intervention as it is pre and post intervention study in one group without control |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescent aged 14 to 19 who has resided in the study area for at least six months |
|
| ExclusionCriteria |
| Details |
Adolescents who are unable to communicate
Adolescents who will not be available even after three visits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of knowledge, attitude and practice regarding food label information among adolescents
Difference in knowledge, attitude and practice scores before and after intervention
|
Four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Consumption pattern of ultra-processed food (UPFs) among adolescent
Association of UPFs consumption pattern with the knowledge, attitude and practices of using food labels among adolescents
|
Four weeks |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
17/06/2024 |
| 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 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
|
Most research on nutrition labels targets adult consumers, as it is
considered that food labels do not alter a child’s preferences for buying a
particular type of food. There
is a paucity of studies in India investigating the awareness and usage of food
labels, as well as strategies to enhance the effective use of food label
information.A before and after educational interventional study without control will be conducted in rural area of Delhi to assess the knowledge, attitude and practices of using food label
information among adolescents aged 14 to 19 years and to study the effectiveness of educational intervention on knowledge, attitude and practices of using food label information. |