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

N

Norwegian University of Science and Technology

Status

Begins enrollment in 7 months

Conditions

Overweight Adolescents
Underweight
Obese Adolescents

Treatments

Other: Multicomponent school nutrition intervention
Other: Usual nutrition program

Study type

Interventional

Funder types

Other

Identifiers

NCT07332676
352614 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

2,600 estimated patients

Sex

All

Ages

11 to 15 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,600 participants in 2 patient groups

Receive co-created multicomponent school nutrition intervention and usual nutrition program
Experimental group
Treatment:
Other: Multicomponent school nutrition intervention
Usual nutrition program
Active Comparator group
Treatment:
Other: Usual nutrition program

Trial contacts and locations

2

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Central trial contact

Abhijit Sen, PhD

Data sourced from clinicaltrials.gov

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