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

Lead Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05265572
• Other study ID #: Mining Intervention Study
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2022
• Source: University of Johannesburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 576
• Est. completion date: September 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Children between the ages of one and five years

Exclusion Criteria:

• Children above 5 years

Related Conditions & MeSH terms

• Lead Poisoning
• Poisoning

Intervention

Behavioral:
• Domestic Hygiene and household hygiene Intervention
A demonstration on the domestic hygiene intervention will be conducted where participants will be guided on optimal cleaning of windowsills, floors and other surfaces with water and detergent, and advised on appropriate method of cleaning. Participants will be provided with a package of cleaning materials (mop, bucket, detergent, hand wash liquid soap and cloth for wet dusting) which will be used during the demonstration, and retained by participants to facilitate sustainability of the intervention during and after the study. Participants will be further engaged in an educational discussion, with the aid of a specially designed educational pamphlet containing information about health effects potentially associated with dust lead exposure from mine dumps and the personal hygiene and domestic hygiene steps that may be followed to reduce dust lead exposure.

Locations

Country	Name	City	State
South Africa	Snake Park, Soweto	Johannesburg	Gauteng

Sponsors (2)

Lead Sponsor	Collaborator
University of Johannesburg	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead exposure level	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	Three months
Secondary	Reference Lead exposure level	A reference level of 5.0 µg/dL for public health intervention of exposure to lead	Three months