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NCT Number: NCT07332676

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.

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Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delhi, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Usual nutrition program

Other

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

Primary outcomes

  1. Proportion of healthy weight adolescents and body mass index for age

    Time frame: At enrollment and at 12 months follow up

    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

Secondary outcomes

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

    Time frame: At enrollment and at 12 months follow up

    A 24 hour dietary recall will be taken (two times during week days and weekends)

  2. Total metabolic equivalent per day (MET per day)

    Time frame: At enrollment and at 12 months follow up

    Use International Physical activity questionnaire for adolescent to measure specific types, frequency and duration across different domains.

  3. Mental wellbeing

    Time frame: At enrollment and at 12 months follow up

    Measured using Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

Study contacts

Contact information is provided by the study sponsor or research team.

Abhijit Sen, PhD

CONTACT

[email protected]

+4773412950

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Institute for Implementation Science and Health
  • Public Health Foundation of India
  • University of Birmingham

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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