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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Proportion of healthy weight adolescents and body mass index for age [Срок оценки: At enrollment and at 12 months follow up]

Вторичные конечные точки (3)

• Total intake of fruits and vegetables, dairy products, meat and beans (protein), whole grains, sugar-sweetened beverages, fast food, and salty snacks [Срок оценки: At enrollment and at 12 months follow up]
• Total metabolic equivalent per day (MET per day) [Срок оценки: At enrollment and at 12 months follow up]
• Mental wellbeing [Срок оценки: At enrollment and at 12 months follow up]

Критерии участия

Критерии включения

• Adolescents studying in grade 7 to 9 (aged 11-15 years) Exclusion criteria:

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Индия · 1 центр

• Delhi — Delhi

Nepal · 1 центр

• Budhanilakantha Municipality — Budhanilakantha

Идентификаторы

NCT: NCT07332676 · 352614 · 352614

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗