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临床试验/NCT05265572
NCT05265572Unknown不适用

Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump

University of Johannesburg2 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2021年9月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
576
试验地点
2
主要终点
Lead exposure level

研究概览

简要总结

The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.

详细描述

A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.

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
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of one and five years

排除标准

  • Children above 5 years

结局指标

主要结局

Lead exposure level

时间窗: Three months

To detect a mean difference in change from baseline to follow-up of -0.5 μg/dL between the control and experimental group, with common standard deviation of 2 μg/dL

次要结局

  • Reference Lead exposure level(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Mokoatle

Principal Investigator

University of Johannesburg

研究点 (2)

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