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

NCT07332676 | Not Yet Recruiting DMC

• 1 other identifier: 352614
• Study Type: interventional
• Target: 2,600
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Overweight Adolescents; Underweight; Obese Adolescents

Keywords

nutrition; multicomponent nutrition intervention; co-creation; adolescent; low resource settings; Poor nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total intake of fruits and vegetables, dairy products, meat and beans (protein), whole grains, sugar-sweetened beverages, fast food, and salty snacks

  At enrollment and at 12 months follow up

• Total metabolic equivalent per day (MET per day)

  At enrollment and at 12 months follow up

• Mental wellbeing

  At enrollment and at 12 months follow up

Study Arms (2)

Receive co-created multicomponent school nutrition intervention and usual nutrition program

EXPERIMENTAL

Other: Multicomponent school nutrition intervention

Usual nutrition program

ACTIVE COMPARATOR

Other: Usual nutrition program

Interventions

Multicomponent school nutrition intervention OTHER

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.

Receive co-created multicomponent school nutrition intervention and usual nutrition program

Usual nutrition program OTHER

Usual nutrition program that is being implemented, no any additional active intervention

Usual nutrition program

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Institute for Implementation Science and Health: collaborator
• Public Health Foundation of India: collaborator
• University of Birmingham: collaborator

Study Sites (2)

Delhi

Delhi, India

Location

Budhanilakantha Municipality

Budhanilakantha, Bagmati, Nepal

Location

MeSH Terms

Conditions

Thinness; Malnutrition

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Archana Shrestha, PhD

  Institute for Implementation Science and Health

  PRINCIPAL INVESTIGATOR

• Monica Arora, PhD

  Public Health Foundation India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Sen, PhD

CONTACT

+4773412950; abhijit.sen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will utilise a hybrid type II approach to assess effectiveness and implementation using a parallel arm cluster RCT design with 12 months follow up

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1); IN (1)