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CTRI Number  CTRI/2025/09/095400 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   #BetterNutrition4Adolescent 
Scientific Title of Study   Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Monika Arora 
Designation  Vice President Research and Health Promotion  
Affiliation  Public Health Foundation of India (PHFI) 
Address  Public Health Foundation of India (PHFI) House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi South DELHI 110030 India

South
DELHI
110030
India 
Phone  9810056631  
Fax    
Email  monika.arora@phfi.org  
 
Details of Contact Person
Scientific Query
 
Name  Prof Monika Arora 
Designation  Vice President Research and Health Promotion  
Affiliation  Public Health Foundation of India (PHFI) 
Address  Public Health Foundation of India (PHFI) House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi South DELHI 110030 India


DELHI
110030
India 
Phone  9810056631  
Fax    
Email  monika.arora@phfi.org  
 
Details of Contact Person
Public Query
 
Name  Prof Monika Arora 
Designation  Vice President Research and Health Promotion  
Affiliation  Public Health Foundation of India (PHFI) 
Address  Public Health Foundation of India (PHFI) House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi South DELHI 110030 India


DELHI
110030
India 
Phone  9810056631  
Fax    
Email  monika.arora@phfi.org  
 
Source of Monetary or Material Support  
Norwegian University of Science and Technology, Postbox 8900, 7491 Trondheim, Norway 
 
Primary Sponsor  
Name  Public Health Foundation of India (PHFI)  
Address  Public Health Foundation Of India, House No. 60 4th Floor Lane 2, Part of Saidulajab Extension, Near Saket Metro Station Gate No. 2 New Delhi 110030  
Type of Sponsor  Other [NGO] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Monika Arora  Public Health Foundation of India   Public Health Foundation Of India, House No. 60 4th Floor Lane 2, Part of Saidulajab Extension, Near Saket Metro Station Gate No. 2 New Delhi 110030
South
DELHI 
9810056631

monika.arora@phfi.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Public Health Foundation of India-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School going adolescents aged 11-14 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multicomponent Intervention (MI) package - #BetterNutrition4Adolescent  The components for co-creating the Multicomponent Intervention (MI) package will be guided by the WHOs ‘Best Buys’ that include interventions to reduce salt and sugar intake, educational initiatives, and measures to eliminate trans-fats. The MI will focus on three levels- Level 1 - For students to increase food and nutrition literacy, Level 2- Creating an enabling school environment for making healthy choices, and Level 3 - For canteen staff and food vendors to increase food and nutrition literacy to sell healthy food. The intervention will be implemented over 12 months. 
Comparator Agent  No intervention   No intervention related to food behaviour and environment will be provided to control group 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Adolescents studying in grades 7 to 9 (aged 11-14 years) will be recruited from private and public schools 
 
ExclusionCriteria 
Details  Adolescents with siblings enrolled in schools assigned to a different trial arm to avoid clustering, with underlying medical conditions, and those who plan to change school within one year of enrollment (during the follow-up period) will be excluded 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the difference in the proportion of normal weight adolescents in the intervention and control at 12 months follow up. We hypothesize promoting healthy food behaviour and environment in school would increase the proportion of normal weight by decreasing the proportion of overweight, obese, and underweight adolescents.  12 months follow-up followed by baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes will be measured by the diet quality questionnaire adopted for India which consists of 29 questions, physical activity measured by the global physical activity questionnaire, and mental wellbeing.  12-month follow-up 
 
Target Sample Size   Total Sample Size="2600"
Sample Size from India="1300" 
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)   15/10/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
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  

Project Summary:

The study aims to co-create, implement, and robustly evaluate an innovative multicomponent intervention (MI) that addresses adolescents’ current and future health.

The specific objectives are:

Objective 1: Community-engaged co-creation of a contextual MI to promote healthy food behaviour and environment in schools.

Objective 2: Implement and evaluate the MI in schools in India and assess effectiveness on the proportion of normal-weight adolescents as primary outcome and secondary outcomes such as global dietary recommendation score (GDRS), physical activity, and mental well-being score.

Objective 3: Evaluate the implementation of MI using the RE-AIM framework, assessing reach, adoption, implementation, and maintenance.

Objective 4: Conduct a cost-effectiveness analysis to change BMI (from overweight/obese/underweight to normal weight) and improve GDRS.

Research questions and hypotheses, theoretical approach, and methodology

The overarching research question guiding this project is: How can adolescents be supported and encouraged to adopt healthy food behaviour through co-created MI in school? Based on the state of the art, professional experience, and previous pilot project findings, our hypotheses are:

1.       Adequate understanding of the context (stakeholders, resources, facilitators, and barriers) is needed to effectively engage communities in co-creation. (Work package (WP) 1)

2.       MI package co-created with stakeholders will be acceptable to the end-users and foster ownership and adaptation. (WP2 and 4)

3.       Healthy food behaviour and environment in schools can reduce overweight and underweight and promote physical and mental health. (WP3)

4.       Providing school-wide intervention will reinforce behaviours through peer support. (WP3)

5.       Improvements in adolescent BMI occurs through multiple pathways (knowledge and supportive school environment). (WP3)

6.       Understanding of the mechanisms behind the interventions’ effects will guide future scale up. (WP4)

7.       It will be cost-effective to implement a co-created MI package in schools. (WP5)

This study will collect qualitative and quantitative data through various methods, categorized under different Work Packages (WPs):

Work Package 1 (WP1): In-depth Interviews (IDIs): Conducted with principals, teachers, school administrators, canteen staff, food vendors, and parents of 7-10 grade students. Focus Group Discussions (FGDs): Conducted with students

Work Package 3 (WP3): Anthropometric Measurements: Height and weight will be measured at baseline and follow-up to calculate BMI. The primary outcome is the difference in the proportion of normal-weight adolescents between the intervention and control groups at 12 months.

Dietary Intake & Quality: Measured using a diet quality questionnaire adapted for India (29 questions). Physical Activity Levels: Assessed using the Global Physical Activity Questionnaire (GPAQ). Mental Well-being.

Demographic & Socioeconomic Data: Includes age, gender, education, and environmental factors, collected at baseline and follow-up.

Work Package 4 (WP4):  Survey on Willingness for Healthy Dietary Choices: Adolescents will rate their likelihood of choosing specific healthy food options for lunch or snacks on a Likert scale (1–5). Focus Group Discussions (FGDs): Six FGDs will be conducted with teachers (n=3) and adolescents (n=3). Key Informant Interviews (KIIs): A total of n=16 will be conducted with key stakeholders, including public health and education officers, school principals, canteen staff, and food vendors, to assess facilitators and barriers to implementation.

 
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