Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multicomponent school nutrition intervention, Usual nutrition program.
- Who it may be relevant to
- Registry conditions: Overweight Adolescents, Underweight, Obese Adolescents. Basic parameters: 11 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India, Nepal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - Other Usual nutrition program
Usual nutrition program that is being implemented, no any additional active intervention
Primary outcome measures
- Proportion of healthy weight adolescents and body mass index for age [Time frame: At enrollment and at 12 months follow up]
Secondary outcome measures (3)
- 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]
- Total metabolic equivalent per day (MET per day) [Time frame: At enrollment and at 12 months follow up]
- Mental wellbeing [Time frame: At enrollment and at 12 months follow up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
India · 1 center
- Delhi — Delhi
Nepal · 1 center
- Budhanilakantha Municipality — Budhanilakantha
Identifiers
NCT: NCT07332676 · 352614 · 352614