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

Not Applicable

• Conditions: Lead Poisoning; Lead Poison Children
• Interventions: Behavioral: Domestic Hygiene and household hygiene Intervention

• Registration Number: NCT05265572
• Lead Sponsor: University of Johannesburg

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-07-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

• Children between the ages of one and five years

Exclusion Criteria

• Children above 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Domestic Hygiene and household hygiene Intervention	The group that will receive the intervention to apply

Primary Outcome Measures

Name	Time	Method
Lead exposure level	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

Secondary Outcome Measures

Name	Time	Method
Reference Lead exposure level	Three months	A reference level of 5.0 μg/dL for public health intervention of exposure to lead

Trial Locations

Locations (1)

Snake Park, Soweto; 🇿🇦 Johannesburg, Gauteng, South Africa