Healthy School mEAls With Less Salt：an Action to Reduce Salt Intake in School Meals for Children in Rural China（HEALS-child）
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16,000
- 主要终点
- Primary outcome for the main study-Systolic blood pressure
研究概览
简要总结
This study aims to assess the impact of the HEALS-Child action project on children's health in rural China. The goal of the project is to evaluate the effectiveness, feasibility, safety and cost-effectiveness of two salt reduction strategies: replacing usual salt with salt substitute in school meals, and replacing bowls with trays in school cafeteria. The study has two parts: the main study evaluates the salt substitute intervention, and the ancillary study evaluates the tray intervention. In the main study, over 16000 students from around 320 elementary or junior high school in rural China will be cluster-randomized into the two groups: 1. Salt substitute 2.usual salt. The primary outcome in the main study will be the change in systolic blood pressure. In the ancillary study, over 500 students from 10 elementary or junior high school will be cluster-randomized into the two groups: 1. meal trays 2.bowls. The primary outcome in the ancillary study will be the change in spot urine sodium. The interventions will last over 1 years. To evaluate the impact of interventions, 50 students were randomly selected from each school.
详细描述
The HEALS-Child action（Healthy School mEAls With Less Salt：an Action to Reduce Salt Intake in School Meals for Children in Rural China）is a project launched by China Development Research Foundation, aiming to reduce the salt in school meals and improve the nutrition for rural students. The goal of the study is to evaluate the effectiveness, feasibility, safety and cost-effectiveness of two salt reduction strategies: replacing usual salt with salt substitute in school meals, and replacing bowls with trays in school cafeteria. The study has two parts: the main study evaluates the salt substitute intervention, and the ancillary study evaluates the tray intervention.
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Main study:
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Aims:
The aim in the main study is to test if replacing usual salt with the market available salt substitute in school meals could significantly reduce systolic blood pressure among rural school student. The corresponding null hypotheses in the main study is: the mean change from the baseline in systolic blood pressure of the students in schools that are supplied with salt substitute is equal to that in schools that are supplied with usual salt. 2. Study design:
In the main study, over 16000 students from around 320 elementary or junior high school in rural China will be cluster-randomized into the two groups: 1. Salt substitute 2.usual salt. The salt substitute (NaCl 75% and KCl 25%) will be centrally provided. The intervention will last for two semesters(around 10-months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attend school stably in this academic year, and expect to take no more than one month of leave for the whole academic year； Have lunch at school at least three times a week.
排除标准
- •Unable to complete the baseline blood pressure measurement and spot urine collection.
结局指标
主要结局
Primary outcome for the main study-Systolic blood pressure
时间窗: 10-month
The change in systolic blood pressure from baseline to follow-up
Primary outcome for the ancillary study-Spot urinary sodium
时间窗: 10-month
The change in spot urinary sodium from baseline to follow-up
次要结局
- Secondary outcome for the main study-Incidence of hypertension(10-month)
- Secondary outcome for the main study-ICER(10-month)
- Secondary outcome for the main study-Spot urinary potassium(10-month)
- Secondary outcome for the main study-Diastolic blood pressure(10-month)
- Secondary outcome for the ancillary study-ICER(10-month)
- Secondary outcome for the main study-Spot urinary sodium(10-month)