| CTRI Number |
CTRI/2026/02/104209 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to see whether collaboration between parents and teachers can reduce consumption of packaged and junk foods among school children |
|
Scientific Title of Study
|
Feasibility of Parent-Teacher Collaboration (PaTTERN) in Reducing Ultra-Processed Food Consumption
among school children: A Pilot 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 |
Pranab Mahapatra |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences, Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha
Kalinga Institute of Medical Sciences, Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha, 751024
Khordha
ORISSA
751024
India |
| Phone |
7752085533 |
| Fax |
|
| Email |
drpranab@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somen Kumar Pradhan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Community Medicine,M.K.C.G Medical College, Berhampur |
| Address |
Room No. 129, Department of Community Medicine, Academic Building,M.K.C.G Medical College, Berhampur, District - Ganjam, Odisha
Room No. 129, Department of Community Medicine, Academic Building,M.K.C.G Medical College, Berhampur,District - Ganjam, Odisha,760004
Ganjam
ORISSA
760004
India |
| Phone |
09439705642 |
| Fax |
|
| Email |
somenpradhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somen Kumar Pradhan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Community Medicine,M.K.C.G Medical College, Berhampur |
| Address |
Room No. 129, Department of Community Medicine, Academic Building,M.K.C.G Medical College, Berhampur, District - Ganjam, Odisha
Room No. 129, Department of Community Medicine, Academic Building,M.K.C.G Medical College, Berhampur,District - Ganjam, Odisha,760004
Ganjam
ORISSA
760004
India |
| Phone |
09439705642 |
| Fax |
|
| Email |
somenpradhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bernard Lown Scholar Program,Department of Global Health and Population
Harvard T.H. Chan School of Public Health,
677 Huntington Avenue
Building 1, 11th Floor, Room 1107
Boston, MA 02115 |
|
|
Primary Sponsor
|
| Name |
Harvard T.H. Chan School of Public Health |
| Address |
Department of Global Health and Population
Harvard T.H. Chan School of Public Health
677 Huntington Avenue
Building 1, 11th Floor, Room 1107
Boston, MA 02115,USA |
| Type of Sponsor |
Research institution |
|
|
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 Somen Kumar Pradhan |
Ganjam District |
Room No. 129, Department of Community Medicne,M.K.C.G Medical College, Berhampur, District - Ganjam, Odisha. Pin: 760004
Ganjam
ORISSA |
9439705642
somenpradhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PaTTERN school based healthy eating intervention |
The intervention includes three core components. First parent teacher workshops to increase awareness regarding health risks of ultra processed food and to co develop school level dietary guidelines. Second student educational activities including classroom sessions and motivational prompts promoting healthy food choices. Third modification of the school food environment including guidance on food brought from home and monitoring of ultra processed food consumption within school premises.The total period of the intervention will be for 6 months. |
| Comparator Agent |
Standard school practices without PaTTERN intervention |
Schools allocated to the control group will continue with their usual school practices without implementation of the PaTTERN healthy eating intervention. No structured parent teacher collaboration activities educational workshops or school food policy modifications related to ultra processed food reduction will be introduced during the study period. Data collection procedures including baseline and follow up assessment of ultra processed food consumption dietary diversity and other study outcomes will be conducted in the same manner as in intervention schools for comparison purposes. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Public-funded, non-residential schools.
2.Schools catering to students aged 10–15 years.
3.Schools willing to participate in the full study period (baseline and follow-up assessments).
4.Schools providing written administrative consent.
5. Schools not currently implementing a structured parent-teacher healthy eating policy similar to PaTTERN. |
|
| ExclusionCriteria |
| Details |
1.Residential/boarding schools.
2.Schools currently running a structured eat-right/food-restriction intervention involving parents.
3.Schools unwilling to allow observation of food consumption or data collection activities.
4.Schools planning major structural changes (closure/merger) during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in weekly ultra-processed food consumption events per 100 students. |
0,3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility indicators including stakeholder participation rate intervention adherence implementation fidelity and satisfaction levels assessed during and at the end of the intervention period. |
0,3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
01/07/2026 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpranab@outlook.com].
- For how long will this data be available start date provided 01-12-2028 and end date provided 01-12-2033?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to co design implement and evaluate the feasibility and effectiveness of a school based healthy eating policy titled Parent Teacher Teaming up for Enhancement of Responsible Nutrition PaTTERN to reduce ultra processed food consumption among school children aged 10 to 15 years in rural Odisha India. The intervention will be developed through stakeholder engagement involving parents teachers and students using an implementation research framework. The study will follow a non randomized controlled pre post quasi experimental design with three intervention schools and three control schools. The primary outcome will be reduction in the mean number of ultra processed food consumption events per week among students. Secondary outcomes include changes in dietary diversity nutritional knowledge stakeholder engagement and selected urinary metabolic biomarkers assessed in a sub sample of students.
The study hypothesizes that schools implementing the PaTTERN intervention will demonstrate a greater reduction in ultra processed food consumption compared to control schools and that parent teacher collaboration will be feasible acceptable and sustainable within the school setting.
|