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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-15
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adolescents studying in grade 7 to 9 (aged 11-15 years)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multicomponent school nutrition intervention

    Other 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.

  • Usual nutrition program

    Other intervention

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

Treatment groups

2,600 Participants
are divided into 2 treatment groups
Group A: Receive co-created multicomponent school nutrition intervention and usual nutrition programExperimental treatment 1 intervention
Group B: Usual nutrition programActive comparator 1 intervention

Trial outcomes

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

Time frame
At enrollment and at 12 months follow up

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

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

Time frame
At enrollment and at 12 months follow up
2

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.

Time frame
At enrollment and at 12 months follow up
3

Mental wellbeing

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

Time frame
At enrollment and at 12 months follow up

Other outcomes

Sponsors and contacts

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Norwegian University of Science and Technology

Lead sponsor

Institute for Implementation Science and Health

Collaborator

Public Health Foundation of India

Collaborator

University of Birmingham

Collaborator

This trial is not recruiting at the moment. You can still explore other options: