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临床试验/NCT07332676
NCT07332676
尚未招募
不适用

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

Norwegian University of Science and Technology2 个研究点 分布在 2 个国家目标入组 2,600 人开始时间: 2026年10月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
2,600
试验地点
2
主要终点
Proportion of healthy weight adolescents and body mass index for age

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Receive co-created multicomponent school nutrition intervention and usual nutrition program

Experimental

干预措施: Multicomponent school nutrition intervention (Other)

Usual nutrition program

Active Comparator

干预措施: Usual nutrition program (Other)

结局指标

主要结局

Proportion of healthy weight adolescents and body mass index for age

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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