Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent

The goal of this clinical trial is to learn if a multicomponent nutrition program developed together with the students, parents, teachers and canteen operators will improve nutrition status of adolescents. It will also learn about the acceptability and feasibility of implementing the program in the school settings. The main questions it aims to answer are:

What is the effect of co-created multicomponent intervention promoting healthy food behavior and environment in schools on the proportion of normal weight adolescents? What proportion of the target adolescents and teachers does the intervention reach? What proportion of the schools are willing to implement the intervention? What was the level of fidelity of implementation of all components of the intervention and the barriers and facilitators to implementation? What is the cost for maintenance, and facilitators and barriers of sustainment? School going adolescents studying in grades 7 to 9 from 26 schools in India and 26 schools in Nepal will be enrolled in the trial and their height, weight, dietary behavior, mental well-being and physical activity will be measured at baseline and at 12 months follow up. After the baseline assessment the school community (students, school environment, parents, teachers, canteen operators) will receive the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight Adolescents; Underweight; Obese Adolescents
• Intervention / Treatment: Other: Multicomponent school nutrition intervention; Other: Usual nutrition program

• Study Type: Interventional
• Enrollment (Estimated): 2600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abhijit Sen, PhD; Phone Number: +4773412950; Email: abhijit.sen@ntnu.no

Study Locations

• India
  • Delhi, India
    • Delhi
• Nepal
  • Bagmati
    • Budhanilakantha, Bagmati, Nepal
      • Budhanilakantha Municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents studying in grade 7 to 9 (aged 11-15 years) Exclusion criteria:

Exclusion Criteria:

• 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 follow up period) will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receive co-created multicomponent school nutrition intervention and usual nutrition program	Other: Multicomponent school nutrition intervention; The intervention will include innovative components that aims to change school food environment, nutrition education to promote healthy eating and community and parental involvement. This section will be completed after the intervention package is finalized during the co-creation phase.
Active Comparator: Usual nutrition program	Other: Usual nutrition program; Usual nutrition program that is being implemented, no any additional active intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of healthy weight adolescents and body mass index for age	Height and weight of the adolescents will be measured to calculate body mass index using age and sex specific charts and categorize them as Underweight: Less than the 5th percentile, Healthy weight: 5th percentile up to the 85th percentile , Overweight: 85th percentile to less than the 95th percentile, Obesity: 95th percentile or higher	At enrollment and at 12 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intake of fruits and vegetables, dairy products, meat and beans (protein), whole grains, sugar-sweetened beverages, fast food, and salty snacks	A 24 hour dietary recall will be taken (two times during week days and weekends)	At enrollment and at 12 months follow up
Total metabolic equivalent per day (MET per day)	Use International Physical activity questionnaire for adolescent to measure specific types, frequency and duration across different domains.	At enrollment and at 12 months follow up
Mental wellbeing	Measured using Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	At enrollment and at 12 months follow up

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Public Health Foundation of India; University of Birmingham; Institute for Implementation Science and Health
• Investigators: Principal Investigator: Archana Shrestha, PhD, Institute for Implementation Science and Health; Principal Investigator: Monica Arora, PhD, Public Health Foundation India

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: adolescent; nutrition; low resource settings; Poor nutrition; co-creation; multicomponent nutrition intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Thinness
• Other Study ID Numbers: 352614 (Other Grant/Funding Number: Research Council Norway)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No